EINSTEIN HEALTHCARE NETWORK CANCER CENTER ACTIVE … Clinical Trials.pdf · Gastrointestinal –...
Transcript of EINSTEIN HEALTHCARE NETWORK CANCER CENTER ACTIVE … Clinical Trials.pdf · Gastrointestinal –...
1
EINSTEIN HEALTHCARE NETWORK CANCER CENTER
ACTIVE CLINICAL TRIALS
2
TABLE OF CONTENTS
PAGE
Studies by Organ/System
3
Brain
4 - 6
Breast – Neoadjuvant/Adjuvant
6
Breast – Advanced/Metastatic
7-8
Gastrointestinal – Colorectal – Adjuvant
9 Gastrointestinal –Advanced, Metastatic
10
Gastrointestinal –Hepatocellular
11 Gastrointestinal –Pancreatic
12-13 Genitourinary – Prostate
14 Gynecological
15-16
Head and Neck
17 Myeloma
18-20
Lung – NSCLC
21-22
Lung – SCLC/Thymoma, Thymic Carcinoma/Mesothelioma
23-24
25
Supportive care
Multiple cancer diagnoses
26
27
Trials pending activation
ECOG Path. Coordinating Ctr Information “NEW” 10/24/2014
3
BRAIN PROTOCOL CONTACTS
Radiation Oncology Investigator – Kenneth Zeitzer, MD 215-456-6280
Coordinator – Jeff Mealey, RN 215-456-6316
No active studies at this time.
4
BREAST PROTOCOL CONTACTS
MEDICAL ONCOLOGY Investigator – Mark S. Morginstin, DO 215-456-3880
Coordinator – Joann R. Ackler, RN, OCN, CCRP 215-456-8295
RADIATION ONCOLOGY Investigator – Angelica T. Montesano, MD 215-456-6280
Coordinator – Jeff Mealy, RN 215-456-6316
STUDY# ADJUVANT
TITLE and ELIGIBILITY CRITERIA THERAPY
NRG BR-003/
CIRB-005
# Pts: _____
Initial approval 3/21/2016
CIRB Approval expires 2/17/17
A Randomized Phase III Trial of Adjuvant Therapy
Comparing Doxorubicin Plus Cyclophosphamide Followed by
Weekly Paclitaxel with or without Carboplatin for Node-
Positive or High-Risk Node Negative Invasive Breast Cancer
Eligibility: Unilateral breast IDC: pT1-3; pN0 – pN3b,
underwent mastectomy or clear margins on lumpectomy/re-
excision; ER, PR, & HER2 negative (please see pgs. 14-15 of
protocol for specifics). < 60 days from last surgery to
randomization. Adequate organ function/lab values (see pgs. 15
& 16 of protocol); Please refer to section 3.3, pgs. 16 & 17 for
exclusion criteria details.
Arm 1:
Doxorubicin 60 mg/M2 IV
Cyclophosphamide 600 mg/m2 IV
Q 2 Weeks X 4 cycles
Followed by:
Paclitaxel 80 mg/m2 IV weekly x 12 doses
Arm 2:
Doxorubicin 60 mg/M2 IV
Cyclophosphamide 600 mg/m2 IV
Q 2 Weeks X 4 cycles
Followed by:
Paclitaxel 80 mg/m2 IV weekly x 12 doses and
Carboplatin AUC 5 IV Q 3 weeks
5
STUDY# ADJUVANT
TITLE and ELIGIBILITY CRITERIA THERAPY
RTOG 1014
A Phase II study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma Closed to accrual 6/18/13
Partial Breast Re-Irradiation (PBrI)
3D-Conformal External Beam
1.5 GY x 15 (BID) to 45 Gy Total
Patient Population:
� Histopathologic confirmation via lumpectomy of local in-breast
ipsilateral recurrence
� Final breast surgery (lumpectomy and/or final re-excision) within
42 days prior to study entry;
� Initial lumpectomy followed by whole breast radiation >1 year
prior to study entry;
� Ipsilateral breast mammogram and MRI within 120 days prior to
study entry. Contralateral breast
mammogram within 12 months of study entry.
� Negative histologic margins of resection, no tumor on ink,
following breast-preserving surgery of local recurrence.
Partial Breast Re-Irradiation (PBrI)
3D-Conformal External Beam
1.5 GY x 15 (BID) to 45 Gy Total
RTOG 1005
A PHASE III TRIAL OF
ACCELERATED WBI WITH
HYPOFRACTIONATION PLUS
CONCURRENT BOOST
Vs. STANDARD WBI
PLUS SEQUENTIAL BOOST FOR
EARLY-STAGE BREAST CANCER
Patient Population:
pStage 0, I, II Breast Cancer resected by lumpectomy
ypStage 0, I,II Breast Cancer resected by lumpectomy that
followed neoadjuvant systemic therapy
ARM 1: Standard fractionation
Whole Breast 50.0 Gy/25 fractions/2.0 Gy daily
Optional fractionation of 42.7Gy in 16 fractions permissible
Sequential Boost 12.Gy/6 fractions/2.0 Gy daily or
14.0Gy/7fractions/2Gy daily
ARM 2: Hypofractionation (15 fractions total)
Whole Breast 40 Gy/15 fractions/2.67 Gy daily
Concurrent boost 48.0 Gy/3.2 Gy daily
6
BREAST – Advanced/Metastatic E2112
CIRB-004
# Pts. = _____
Initial NCI-CIRB AEHN approval
2/4/2016
Expires May 20, 2016
A Randomized Phase III Trial of Endocrine Therapy plus
Entinostat/Placebo in Postmenopausal Patients with
Hormone Receptor-Positive Advanced Breast Cancer
Eligibility:ER or PR (+) hist. confirmed adeno ca; must be HER2
neg.; Stage III/locally advanced or metastatic not suitable for
therapy of curative intent. Meas or non-meas disease evaluated <
4 wks. Please see eligibility checklist for complete entry criteria
[protocol section 3.1, pages 19-22].
Arm A:
Exemestane 25 mg PO daily x 28 days
Entinostat 5 mg PO days 1, 8, 15, & 22
Arm B:
Exemestane 25 mg PO daily x 28 days
Placebo 5 mg PO days 1, 8, 15, & 22
A cycle = 28 days
7
GI PROTOCOL CONTACTS – ANAL, COLORECTAL, ESOPHAGEAL, GASTRIC,
HEPATOCELLULAR, PANCREATIC, & GIST
Medical Oncology: Investigator – John Leighton, MD 215-456-3880
Coordinator – Joann R. Ackler, RN, OCN, CCRP 215-456-8295
Radiation Oncology: Investigator – Kenneth Zeitzer, MD 215-456-6285
Coordinator – Jeff Mealy, RN 215-456-6316
GASTROINTESTINAL STUDIES – Esophagus & Gastric – No active studies at this time.
8
GASTROINTESTINAL – Adjuvant/Resected Colon
C80702
Stage III
(H) N-4285
# Pts. 5
Accrual goal = 10 / 2,500
Study Nurse: Joann Ackler
Closed to accrual
11.20.15
Update #7 approved 3/16/2015
IRB Approval Expires
September 17, 2016
Phase III Trial of 6 vs. 12 Treatments of Adjuvant Folfox +
Celecoxib/Placebo for Patients with Resected Stage III Colon
Cancer
Eligibility: Hist. proven Adenocarcinoma; margin > 12 cm from
anal verge & completely resected – R0 resection must be in
operative report; > 1 + lymph node or N1C [see AJCC v. 7];
synchronous colon primaries OK; PS 0-2; adequate hematologic,
renal, & hepatic function; NO -- evidence of residual nodal or
metastatic disease; NSAIDS or ASA use > 3 x/wk; prior or
concurrent malignancy except in situ skin cancer unless NED > 5
yrs; neuro-toxicity > Gr 2; history UGI ulcers, bleed, or
perforation x 3yrs; uncontrolled HTN, unstable angina, any history
of MI or CVA, NYHA class III/IV CHF; allergy to sulfonamides,
celecoxib, NSAIDS.
Arm A: 6 cycles FOLFOX* + Celecoxib/placebo
(400 mg daily) Q 2 weeks
Arm B: 12 cycles FOLFOX* +
Celecoxib/placebo (400 mg daily) Q 2 weeks
*Oxaliplatin – 85 mg/m2 IV over 2 hrs, followed
by
*Leucovorin 400 mg/m2 IV over 2 hrs, followed
by
*5-FU 400 mg/m2 IV bolus, then 2400 mg/m
2
CIV over 46-48 hrs.
NOTE: Treatment must begin > 21 and < 56
days after definitive resection.
9
GASTROINTESTINAL – Metastatic Colorectal
STUDY# TITLE and ELIGIBILITY CRITERIA THERAPY
2012-PT023-V3.4 WIRB # 20120762
# Pts. =1 (under v2.4); 3 (under v3.4)
Total = 4
Accrual goal = 8 / 650
Study nurse: Joann Ackler
WIRB Initial Approval Date –
5.13.2013,
Version 3.4 -9.22.2015
Expires 5.17.2016
Phase III Double-Blinded, Placebo Controlled Study of
XilonixTM
for Improving Survival in Metastatic Colorectal
Cancer Patients with Cachexia
Eligibility: Path. Confirmed metastatic or unresectable, refractory
colon cancer (refer to protocol pg 30 for required prior therapies);
PS = 0-2; Weight loss in past 6 months must be < 20%; most
recent anti-cancer therapy must be > 2; adequate organ function –
see specific lab parameters pg 29; serum K
+ & Mg
++ levels must
be WNL – OK to replenish to normal prior to enrollment; refer to
pg 31 for specific cardiac status criteria; NO active infections,
HIV, Hepatitis B or C; NO TB history (latent or active) or +
IGRA; AEs from prior trt must be < grade 1.
Restricted therapies:at least 2 weeks since last therapy
including; XRT, chemotherapy, immunotherapy, surgery,
hormonal therapy or targeted biologics; at least 4 weeks since
agents that target IL-1/TNF-alpha.
Study drug (MABp1/placebo)
7.5 mg/kg IV over 1 hour (+/- 15 minutes)
Q 2 weeks
1 hour observation will follow each infusion
*all subjects will receive BSC (best supportive care)
10
GASTROINTESTINAL STUDIES –HEPATOCELLULAR – No active trials effective 11/19/2014
STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY
11
GASTROINTESTINAL STUDIES-PANCREATIC
STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY
RTOG 0848
Study Nurse:
A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant
Treatment for Patients with Resected Head of Pancreas Adenocarcinoma
Primary head of pancreas invasive adenocarcinoma resected (i.e., removal of
all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a
pylorus preserving pancreaticoduodenectomy; IPMN are eligible; T1-3, N0-1,
M-0 eligible.
Ist Randomization
Arm 1: gemcitabine x 5 cycles
Arm 2: gemcitabine + erlotinib x 5 cycles
Evaluate to confirm no progression
2nd
Randomization
Arm 3: 1 cycle same chemotherapy as first
randomization treatment arm
Arm 4: 1 cycle same chemotherapy as first
randomization treatment arm followed by XRT
+ capecitabine or 5-FU
12
GU PROTOCOL CONTACTS- Bladder, Prostate, Renal
RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280
Coordinator – Jeff Mealey, RN 215-456-6316
ECOG/Other: Investigator – William Tester, MD 215-456-3880
Coordinator – Joann Ackler RN, OCN 215-456-8295
13
Prostate
STUDY #
TITLE and ELIGIBILITY CRITERIA THERAPY
RTOG 0534 A PHASE III TRIAL OF SHORT TERM ANDROGEN
DEPRIVATION WITH PELVIC LYMPH NODE OR PROSTATE
BED ONLY RADIOTHERAPY (SPPORT) IN PROSTATE
CANCER
PATIENTS WITH A RISING PSA AFTER RADICAL
PROSTATECTOMY
Lymph node negative adenocarcinoma of the prostate treated with
radical prostatectomy
Post-radical prostatectomy PSA of ≥ 0.1 - < 2.0 ng/mL; pathologic
T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a
positive prostatectomy surgical margin;
Gleason ≤ 9
Arm 1: PBRT alone PBRT 64.8-70.2 Gy
Arm 2: PBRT + NC-STAD PBRT 64.8-70.2 Gy + NC-STAD
for 4-6 months, beginning 2 months before RT
Arm 3: PLNRT + PBRT + NC-STAD
PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy,
NC-STAD for 4-6 months, beginning 2 months before RT
RTOG 0938 A Randomized Phase II Trial Of Hypofractionated Radiotherapy For
Favorable Risk Prostate Cancer-RTOG CCOP Study
Histologically confirmed diagnosis of adenocarcinoma of the
prostate within 180 days of randomization; Gleason
scores 2-6; Clinical stage T1-2a; PSA < 10 ng/mL (PSA should not
be obtained within 10 days after prostate
biopsy).
Treatment techniques/machine
1. All linear accelerator based treatment
(excluding Cyberknife)
2. Cyberknife
3. Protons
Arm 1
36.25 Gy in 5 fractions of 7.25 Gy over two
and a half weeks (in 15-17 days)*
Arm 2
51.6 Gy in 12 daily fractions of 4.3 Gy over
two and a half weeks (in 16-18 days)*
RTOG 0815 H(N)
Study Nurse: Jeff Mealey, RN
A Phase III Prospective Randomized Trial Of Dose-Escalated
Radiotherapy With Or Without Short-Term Androgen Deprivation
Therapy For Patients With Intermediate-Risk Prostate Cancer
Intermediate risk for recurrence as determined by having one or
more of the following: Gleason Score 7; PSA >10 but <20; Clinical
Stage T2b-T2c. Clinically negative lymph nodes as established by
imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or
dissection within 60 days prior to registration, except as noted in
protocol Section 3.1.2. No evidence of bone metastases (M0) on
bone scan
Stratify by Number of Risk Factors; Comorbidity Status; RT
Modality
Arm 1: Dose-escalated RT alone
Arm 2: Dose-escalated RT combined with short-term (6
months) androgen blockade (LHRH agonist + antiandrogen)
14
GYNECOLOGIC
PROTOCOL CONTACTS RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280 Coordinator – Jeff Mealey, RN 215-456-6316
CTSU/GOG/OTHER: Investigator – Claudia Dourado, MD 215-456-3880
Coordinator –
No Active Studies at this time
GYN- CERVICAL STUDY #
TITLE and ELIGIBILITY CRITERIA THERAPY
No Active Studies at this time
GYN-ENDOMETRIAL/PERITONEAL/OVARIAN
STUDY #
TITLE and ELIGIBILITY CRITERIA THERAPY
15
Head & Neck Studies-
RADIATION ONCOLOGY Investigator: Kenneth Zeitzer, MD 215-456-6280
Coordinator: Jeff Mealey, RN 215-456-6316 HEAD & NECK
STUDY #
TITLE and ELIGIBILITY CRITERIA THERAPY
RTOG 0920
A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for
Locally-Advanced Resected Head and Neck Cancer
Pathologically (histologically) proven diagnosis of squamous cell carcinoma
(including variants such as verrucous carcinoma, spindle cell carcinoma,
carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx);
Clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant metastases;
Gross total resection of the primary tumor with curative intent must be completed
within 7 weeks of registration with surgical pathology demonstrating one or
more of the following "intermediate" risk factors:
Perineural invasion;
Lymphovascular invasion;
Single lymph node > 3 cm or > 2 lymph nodes (all < 6 cm) [no
extracapsular extension];
Close margin(s) of resection, defined as cancer extending to within 5
mm of a surgical margin;
T3 or microscopic T4a primary tumor (Note: Gross T4a or T4b is
ineligible);
T2 oral cavity cancer with > 5 mm depth of invasion.
Arm 1: Radiation Therapy Alone, 2 Gy/day, in
30 fractions for a total of 60 Gy*
Arm 2: Radiation Therapy + Cetuximab
At least 5 days prior to RT: Cetuximab:
Initial dose, 400 mg/m2
RT: 2 Gy/day in 30 fractions for a total
of 60 Gy* plus cetuximab, 250
mg/m2/week x 6 weeks
plus cetuximab: 250 mg/m2/week x 4
weeks post-RT
*IMRT is mandatory. Dose is 60 Gy
prescribed to at least 95% of the PTV. If
IGRT is used, it should be daily to assure that
error/variance is < 3.5 mm. Note: 66 Gy is
permitted and optional.
16
STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY RTOG 1016 Phase III Trial of Radiotherapy Plus Cetuximab Versus
Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Patients must be positive for p16, determined by the Innovation Center
CLIA lab at The Ohio
State University (OSU) prior to Step 2 registration (randomization); see 10.2
for details of
tissue submission. Patients must consent to submission of tissue for this
analysis. Patients also
must consent to provide their smoking history by completing that portion of the
computer-assisted self
interview (CASI) head and neck risk factor survey tool.
For this study, IMRT is mandatory. IGRT credentialing is mandatory when
using PTV margins < 5
mm. See Section 5.0 for required pre-registration credentialing for IMRT (and
for IGRT, if used for
margin reduction).
Patient Population: (See Section 3.0 for Eligibility)
Squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate,
or oropharyngeal walls); stage
T1-2, N2a-3, or T3-4 any N; patient tumor must be p16 positive
Arm 1:
Accelerated IMRT, 70 Gy for 6 weeks
+ high dose DDP (100 mg/m2) Days 1 and 22
(Total: 200 mg/m2)
Arm 2:
Accelerated IMRT, 70 Gy for 6 weeks
+ 8 doses of cetuximab (400 mg/m2) loading
dose pre-IMRT, 250 mg/m2 weekly during
IMRT,and for 1 week after IMRT)
17
HEMATOLOGIC PROTOCOL CONTACTS
MULTIPLE MYELOMA
PROTOCOL CONTACTS RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280 Coordinator – 215-456-6316
CTSU/ECOG/OTHER: Investigator – Gabor Varadi, MD 215-456-3880
Coordinator – Joann Ackler, RN OCN 215-456-8295
No Active Studies at this time
18
LUNG PROTOCOL CONTACTS
NSCLC, SCLC
RTOG: Investigator – Kenneth Zeitzer, MD 215-456-6280
Coordinator – Jeffrey Mealey, RN 215-456-6316
ECOG/Others: Investigators – William Tester, MD 215-456-3880
John Leighton, MD 215-827-1570
Coordinators – Joann Ackler RN, OCN, CCRP 215-456-8295
19
LUNG – NSCLC: Adjuvant
STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY
A151216/ALCHEMIST
CIRB-001
Main Study
# Pts. = ___
NCI-CIRB Approval
Expires: 11/18/2016
Adjuvant Lung Cancer Enrichment Marker Identification and
Sequencing Trial (ALCHEMIST)
Eligibility: Completely resected stage IB (> 4cm), II or IIIA non-
squamous NSCLC; adequate FFPE tissue available for central EGFR and
ALK genotyping – Section 3.1, pages 7-8; PS = 0-1; NO neo-adjuvant
therapy for this lung cancer; NO prior treatment targeting EGFR or ALK;
NO second primary lung cancer (considered concurrent malignancy).
If no adjuvant therapy, register patient < 75 days following surgery
If adjuvant chemo. Only, register patient < 165 days following surgery
If adjuvant combination chemo-xrt, register patient < 225 days following
surgery.
A081105/Erlotinib Sub-study
to ALCHEMIST
CIRB-002
# Pts. = ___
NCI-CIRB Approval
Expires: 11/18/2016
Randomized Double Blind Placebo Controlled Study of Erlotinib or
Placebo in Patients with Completely Resected Epidermal Growth
Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer
(NSCLC)
Eligibility: Previously registered to ALCHEMIST w/EGFRexon 19
deletion or L858R mutation; Only prior in situ carcinomas or non-
melanoma skin cancers allowed; NO history of cornea abnormalities
See protocol pages 11-12 for complete list of entry criteria & time to
randomization
Erlotinib/placebo 150 mg/day
1 cycle = 21 days
Duration = up to 2 years if no recurrence or excessive toxicity
E4512/ Crizotinib Sub-study
to ALCHEMIST
CIRB-003
# Pts. = ___
NCI-CIRB Approval
Expires: 6/3/2016
A Phase III Double-Blind Trial for Surgically Resected Early Stage
Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients
with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK)
Fusion Protein
Eligibility: Previously registered to ALCHEMIST; EML4-ALK fusion
gene positive; NO known interstitial fibrosis or interstitial lung disease;
NO use of substances that are potent CYP3A4 inhibitors or inducers (see
Appendix V). See protocol pages 13 -17 for complete entry criteria.
Crizotinib/placebo 250 mg PO BID (Twice a day)
1 cycle = 21 days
Duration = up to 2 years if no recurrence or excessive toxicity
20
Locally Advanced STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY
RTOG 0839
RANDOMIZED PHASE II STUDY OF PRE-OPERATIVE
CHEMORADIOTHERAPY +/- PANITUMUMAB FOLLOWED
BY
CONSOLIDATION CHEMOTHERAPY IN POTENTIALLY
OPERABLE LOCALLY
ADVANCED (STAGE IIIA, N2+) NON-SMALL CELL LUNG
CANCER
Pathologically proven diagnosis Stage IIIA (T1-T3) with a
single primary lung parenchymal lesion and N2 positive
ipsilateral mediastinal nodes
Randomize:
Arm 1: Induction Chemoradiation
Paclitaxel & Carboplatin: 1x/week for 6 weeks
Concurrent RT: 2 Gy/day, 5x/week, for 6 weeks, for a total of 60
Gy
Arm 2: Induction Chemoradiation and Panitumumab
Panitumumab 1x/week for 6 weeks
Paclitaxel & Carboplatin: 1x/week for 6 weeks
Concurrent RT: 2 Gy/day, 5x/week, for 6 weeks, for a total of 60
Gy
All Patients
Reassessment 4 weeks after Induction treatment
Resectable Patients with No Disease
Progression
Surgery within 2 weeks of reassessment
and within 6 weeks of completion of
induction treatment
Inoperable Patients
(inoperable for medical, anatomical, or other reasons)
with No Disease Progression
Patient proceeds to consolidation treatment
within 6 weeks of completion of
induction treatment
Arms 1 and 2: Consolidation Chemotherapy
Paclitaxel & Carboplatin: q21 days x 2
RTOG 0813 SEAMLESS PHASE I/II STUDY OF STEREOTACTIC LUNG
RADIOTHERAPY (SBRT) FOR EARLY STAGE, CENTRALLY
LOCATED, NON-SMALL CELL LUNG CANCER (NSCLC) IN
MEDICALLY INOPERABLE PATIENTS
Patients with stage T1-2, N0, M0, non-small cell lung cancer,
tumor size ≤ 5 cm, who are not candidates for a
complete surgical resection in the opinion of a thoracic
surgeon; only patients with tumors within or touching
the zone of the proximal bronchial tree or adjacent to
mediastinal or pericardial pleura.
Escalating dose levels; at all levels, patients will receive q 2 day
fractionation X 5 fractions over 1.5-2 weeks
LUNG – NSCLC: Advanced/Metastatic (continued)
21
STUDY #
TITLE and ELIGIBILITY CRITERIA THERAPY
E5508
NSCLC Stage IV, 1st Line
(H) N-4269
Study Nurse: Joann Ackler
# Pts: 14
Accrual goal = 20 / 1495
Addendum #10 approved 10/21/14
Administrative changes only
Notice: Step 1 registration closed
to accrual 5.8.15
IRB Approval expires
May 14, 2016
Randomized Phase III Study of Maintenance Therapy with
Bevacizumab, Pemetrexed, or a combination of Bev + Pemetrexed
Following Carboplatin, Paclitaxel & Bevacizumab for Advanced
NSCLC
NSCLC (non-squamous); Stage IV [M1a & M1b or recurrent); PS
= 0-1; Prior adjuvant chemo OK if > 12 months prior to study –
NO prior use of paclitaxel, pemetrexed, or bevacizumab;
NO prior chemo for advanced NSCLC; NO hemoptysis < 4
wks (1/2 tsp.); NO cavitary lung lesions; Treated brain
metastases OK per amendment #7; Prior XRT OK if > 3 wks.
prior to study; adequate heme., renal, & hepatic function; BP
<150/100 @ baseline; NO history of thrombotic or bleeding
disorders < 12 months. NO pre-menopausal women. See
eligibility checklist for complete list of bevacizumab-related
criteria.
Induction:
Paclitaxel 200 mg/m2 IV +
Carboplatin AUC 6 IV +
Bevacizumab 15 mg/kg IV
Q 3 weeks X 4 cycles
Maintenance:
Randomized if SD or PR:
Arm A: Bevacizumab 15 mg/kg IV
Arm B: Pemetrexed 500 mg/M2 IV
Arm C: Bev plus Pem 500 mg/M2 IV
Q 3 weeks until PD
M14-359 (AbbVie)
HN-4708
Study Nurse: Joann Ackler
# Pts:_____
Accrual goal = 10 / 525
Amendment 3 approved9.4.15;
additional ICF language approved
11.20.15
IRB approval expires
December 27, 2016
Randomized, Open-label. Multicenter, Phase III Trial Comparing
Veliparib Plus Carboplatin and Paclitaxel versus Investigator’s
Choice of Standard Chemotherapy in Subjects Receiving First
Cytoxic Chermotherapy for Metastatic or Advanced Non-squamous
NSCLC and who are current or former smokers*
Eligibility: NSCLC – hist/cyt. confirmed & at least predominantly
non-squamous; Must know EGFR/ALK status: if EGFR mutated
or with ALK gene rearrangement, must have progressed after 1st
line targeted therapy. > 1 meas. Lesion by RECIST; PS 0-1;
adequate organ function – see lab criteria, protocol page 6; NO:
peripheral neuropathy > gr.2, NO CNS mets NO seizures < 12
months before study entry; NO prior trt for NSCLC except neo-
adj. or adjuvant therapy > 12months before study entry. Any ext.
beam RT [thoracic] must be completed by 4 weeks or if to bone by
2 weeks before study entry. NO prior treatment with a PARP
inhibitor. NO hist. of other cancer < 3years except in situ cancers
considered cured.
*Defined as currently smoking –or- > 100 smoking events lifetime
and not smoked in past 12 months
Veliparib (ABT-888): 120 mg BID
Days -2 thru 5
Reference (Investigator’s choice) therapy x 6
cycles
Carboplatin: AUC 6 Day 1
Paclitaxel: 200 mg/m2 Day 1
Pemetrexed: 500 mg/m2
Cisplatin: 75 mg/m2
Maintenance Pemetrexed if suitable
1 cycle = 21 days
22
LUNG- SCLC –Limited Stage
STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY
RTOG 0538
CALGB 30610
PHASE III COMPARISON OF THORACIC
RADIOTHERAPY REGIMENS IN PATIENTS WITH
LIMITED SMALL CELL LUNG CANCER ALSO
RECEIVING CISPLATIN AND ETOPOSIDE
No prior chemotherapy or radiotherapy for SCLC.
No prior mediastinal or thoracic radiotherapy
Patients with complete surgical resection of disease are not
eligible.
Schema (1 cycle = 21 days)
Patients will receive 4 cycles of chemotherapy on all arms
Part I:
Arm A:
Radiotherapy (every day, Monday-Friday, for a total of 3 weeks)
XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks
Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)
Cisplatin 80 mg/m2 IV on day 1, every 21 days
Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Arm B:
Radiotherapy (every day, Monday-Friday, for a total of 7 weeks)
XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks
Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)
Cisplatin 80 mg/m2 IV on day 1, every 21 days
Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Arm C:
Radiotherapy (every day, Monday-Friday, for a total of 5 weeks)
XRT: 61.2 Gy Concomitant boost: QD (1.8 Gy/fx), starting on day 1 of Cycle 1 or 2,
every day, for 16 days of treatment; then BID (1.8 Gy/fx) for 9 days of treatment
Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)
Cisplatin 80 mg/m2 IV on day 1, every 21 days
Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Prophylactic cranial irradiation (PCI) should be offered to all patients with a complete or
near complete response (see Section 8.2.9 for further details).
Part II: Based on the results of Part I, the experimental arm with the higher rate of toxic
events will be discontinued and patients will be randomized as follows:
Arm A:
Radiotherapy (every day, Monday-Friday, for a total of 3 weeks)
XRT: 45 Gy BID (1.5 Gy/fx) for 3 weeks, starting on day 1 of Cycle 1 or 2
Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks)
Cisplatin 80 mg/m2 IV on day 1, every 21 days
Etoposide 100 mg/m2 IV over 60-120 minutes on days 1, 2, and Register/ 3, every 21 days
Arm B or C, depending on which arm is less toxic.
Prophylactic cranial irradiation (PCI) should be offered to all patients with a complete or
near complete response (see Section 8.2.9 for further details).
23
LUNG –Small Cell Extensive Stage – No active studies at this time STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY
24
Supportive Care/Observational Studies
STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY Incyte INCB-MA-PV-401
- P. Vera Observational Study
HN-4662 EXP
# Patients = 14
Accrual goal = 27/2,000
PI – Dr. Goldstein
Admin. Letter #2 approved
12/28/15
Initial IRB Approval =
10.13.2014 (site activated by
sponsor 4/28/15 )
Expires July 30, 2016
PROSPECTIVE OBSERVATIONAL STUDYOF PATIENTS
WITH POLYCYTHEMIA VERA IN US CLINICAL
PRACTICES (REVEAL)
Eligibility: PV diagnosis, receiving care including, not ltd to:
surveillance, ASA (> 81 mg), antithrombotic therapy, PHL-
phlebotomy, HU-hydroxyurea, interferon, busulfan, anagrelide; NO
2ndary AML, MDS, prior or planned stem cell transplant,
splenectomy
No intervention per protocol Observational clinical data collection
Questionnaires: baseline & Q 3 months x 3-4 yrs.
Optional blood sampling annually x 3-4 yrs.
EVA-17261-00
HN-4808 exp.
Pts = ________
NOTE: Open only at main
campus (EMCP)
IRB Approval expires 2/24/17
Qualitative Interviews in Patients with Hepatocellular
Carcinoma (HCC): Relevant Items from the Patient-Reported
Outcomes Version of the Common Terminology Criteria for
Adverse Events (PRO-CTCAE)
Eligibility: Confirmation (histologic or clinical) confirmation of
HCC; Child-Pugh A or B; ECOG PS 0-1; may be uninfected or
HBV, HCV positive. NO fibrolamellar or mixed cholangio-
carcinoma, active co-infection with Hep B & C; hepatitis other
than B or C; NO brain mets (known or suspected); NO prior
liver transplant; NO known anti-PD-1/PD-L-1 treatment;
Non-interventional protocol.
One-to-one interview (90 minutes) between study
sponsor and consenting subjects.
Q of L will include:
FACT-Hep
PRO-CTCAE
EQ-5D
25
Supportive Care – Continued
STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY Varenicline (Chantix) Study
Sponsor: Univ. of Penn
Study Contact @ AEMC:
Tracy Kane (215) 456-4709
Extended Duration Varenicline for Smoking among Cancer
Patients: A Clinical Trial
Eligible subjects will be males and females:
1. > 18 years old; self-report smoking, on average, > 5 cigarettes
(menthol and non-menthol)/ week, for the last 6 months.
2. Diagnosed w/cancer (all sites) within the past 5 years; if
diagnosed >5 years ago, diagnosis must be currently active.
3. Karnofsky Score of > 60 or ECOG PS < 2 within 6 months of
enrollment.
4. Able to use varenicline safely, based on a medical evaluation
including medical history and physical examination, and
psychiatric evaluation.
5. Residing in the geographic area for at least 12 months.
6. Women of childbearing potential (based on medical history and
physical exam) must consent to use a medically accepted method of
birth control (e.g., condoms and spermicide, oral contraceptive,
Depo-Provera injection, contraceptive patch, tubal ligation) or
abstain from sexual intercourse during the time they are taking
study medication and for at least one month after the medication
period ends.
7. Able to communicate fluently in English.
8. Capable of giving written informed consent, which includes
compliance with the requirements and restrictions listed in the
combined consent/HIPAA form
Chantix/Varenicline + counseling for 24 weeks versus
12 weeks
Wiser (lymphedema) Study
Sponsor: NCI/Penn
Study Contact @ Penn:
Renata Alford (215) 827-9549
The Women in Steady Exercise Research (WISER) study info
Eligibility Criteria: One year out breast cancer survivors with
lymphedema
The intervention focuses on the effects of
exercise and weight loss.
26
Multiple Cancer Diagnoses (Breast, Ovarian, & Colon)
CPTAC
Study Contacts:
Clinical Proteomics Tumor Analysis Consortium
Eligibility: Breast – page 8 of SOP
Colon – page 21 of SOP
Ovarian – page 26 of SOP
Pre-op blood and surgical tissue (see SOP)
27
Trials Pending Activation – none pending 3.21.16
STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY
28
DATE: October 24, 2014
SUBJECT: ECOG-ACRIN PCO Move
The ECOG Pathology Coordinating Office – Reference Laboratory (PCO) currently located at Northwestern University in Chicago is moving to the new ECOG-
ACRIN Central Biorepository and Pathology Facility (EA CBPF) at The University of Texas M.D. Anderson Cancer Center in Houston effective November 3,
2014. Please DO NOT send any specimens to the new location prior to the effective date.
Effective November 3, 2014, all samples originally intended for shipment to the PCO must be shipped to the new Central Biorepository and Pathology Facility
(EA CBPF) at the address below:
ECOG-ACRIN Central Biorepository and Pathology Facility
MD Anderson Cancer Center
Department of Pathology, Unit 085
Tissue Qualification Laboratory for ECOG-ACRIN, Room G1.3586
1515 Holcombe Blvd
Houston, TX 77030
Phone: Toll Free 1-844-744-2420 (713-745-4440 Local or International Sites)
Fax: 713-563-6506
Email: [email protected]
In order to assist sites, the Sample Tracking System shipment manifests will be updated with this information. Protocols will be updated on a rolling basis, but
please note that regardless of the protocol language all protocol shipments to the PCO must be sent instead to the EA CBPF at M.D. Anderson starting
November 3rd
.
Kit ordering and pre-paid FedEx (as applicable, per protocol) are unaffected by the move.
Shipments to any other banks or investigating laboratories are unaffected by the PCO-EA CBPF move.
While archived materials are in transit to the EA CBPF, shipping of materials to investigators will be processed on a case-by-case basis.
Please contact the ECOG-ACRIN translational science team at [email protected] or (617) 632-3610 with any questions.