Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer



Status:Recruiting
Conditions:Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:October 12, 2016

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A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer

This randomized phase II trial studies how well veliparib or pembrolizumab work with
combination chemotherapy and radiation therapy in treating patients with rectal cancer that
has spread from where it started to nearby tissue or lymph nodes (locally advanced).
Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor
cells to grow and spread. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen,
work in different ways to stop the growth of tumor cells, either by killing the cells, by
stopping them from dividing, or by stopping them from spreading. Radiation therapy uses
high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib or pembrolizumab
with combination chemotherapy and radiation therapy may kill more tumor cells, make the tumor
smaller, and reduce the amount of normal tissue that needs to be removed.

PRIMARY OBJECTIVES:

I. To demonstrate an absolute improvement in neoadjuvant rectal cancer (NAR) score for the
experimental regimen as compared to concurrently randomized control patients.

SECONDARY OBJECTIVES:

I. To compare overall survival (OS). II. To compare disease-free survival (DFS). III. To
compare the rate of pathologic complete response (pCR) (nodes and tumor).

IV. To compare the rate of sphincter preservation.

EXPLORATORY OBJECTIVES:

I. To estimate the rate of disease progression during chemotherapy (prior to chemoradiation).

II. To compare the rate of clinical complete response rate (cCR). III. To compare the rate of
negative circumferential margin. IV. To compare the rate of completion of all cycles of
neoadjuvant chemotherapy.

V. To compare the rate of completion of full course of chemoradiation. VI. To compare the
toxicity and safety between interventions. VII. To explore the correlative molecular
predictors of response and distant failure.

VIII. To explore the relationship between radiographic findings and pathologic outcomes.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive mFOLFOX6 regimen consisting of oxaliplatin intravenously (IV) over 2
hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over
46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 courses in the absence of
disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient
undergo radiation therapy (RT) and receive capecitabine orally (PO) twice daily (BID)
Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours,
leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48
hours on days 1-2. Treatment repeats every 2 weeks for 8 courses in the absence of disease
progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo
RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the
absence of disease progression or unacceptable toxicity.

ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours,
leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48
hours on days 1-2. Treatment repeats every 2 weeks for 8 courses in the absence of disease
progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo
RT and receive capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab
IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 courses in the absence
of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and every 6 months
for up to 3 years.

Inclusion Criteria:

- The patient must have signed and dated an Institutional Review Board (IRB)-approved
consent form that conforms to federal and institutional guidelines

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Diagnosis of adenocarcinoma of the rectum with the major portion of the tumor intact;
Note: prior to randomization, the investigator must specify and document each of the
following:

- Distance of the lowest tumor margin from the anal verge; and

- Intent for sphincter sparing or non-sphincter sparing surgical resection
according to the primary surgeon; and

- The majority of the untreated tumor must be < 12 cm from the anal verge or below
the peritoneal reflection as determined by the treating surgeon

- The tumor must be clinically determined to be locally advanced stage II or stage III
rectal cancer, and must also meet any ONE of the following criteria:

- Distal location (as defined by measurement on magnetic resonance imaging [MRI],
transrectal ultrasound [ERUS]/pelvic computed tomography [CT] [with IV contrast]
scan or palpable on digital rectal examination [DRE]): cT3-4 =< 5 cm from the
anal verge, any N

- Bulky: any cT4 or evidence that the tumor is adjacent to (defined as within 3 mm
of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan

- High risk for metastatic disease with 4 or more regional lymph nodes (cN2);
clinical nodal or "cN" status for eligibility includes the total number of nodes
(N2 = 4 or more) in the mesorectal and superior rectal stations measuring >= 1.0
cm in any axis on cross sectional or endoscopic imaging; Note: nodes must measure
1.0 cm or greater to be considered positive for this eligibility requirement

- Not a candidate for sphincter-sparing surgical resection prior to neoadjuvant
therapy (as planned by the primary surgeon)

- Note: clinical stage of the primary tumor and nodes may be determined
locally by rectal endoscopic ultrasound or pelvic MRI (MRI is strongly
preferred); CT scan with IV contrast is acceptable provided there is
evidence of T4 and/or N2 disease

- Patients must have the ability to swallow and retain oral medication

- Absolute neutrophil count (ANC) must be >= 1200/mm^3 within 28 days before
randomization

- Platelet count must be >= 100,000/mm^3 within 28 days before randomization

- Hemoglobin must be >= 10 g/dL within 28 days before randomization

- Total bilirubin must be =< ULN (upper limit of normal) for the lab unless the patient
has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar
syndrome involving slow conjugation of bilirubin within 28 days before randomization

- Alkaline phosphatase must be =< 3 x ULN for the lab within 28 days before
randomization

- Aspartate aminotransferase (AST) must be =< 3 x ULN for the lab within 28 days before
randomization;

- Note: if alanine aminotransferase (ALT) is performed instead of AST (per
institution's standard practice), the ALT value must be =< 3 x ULN; if both were
performed, the AST must also be =< 3 x ULN; if AST and/or ALT is >= ULN but =< 3
x ULN, serologic testing for hepatitis B and C must be performed and results for
viral infection must be negative

- Serum creatinine =< ULN for the lab and measured or calculated creatinine clearance >
60 mL/min within 28 days before randomization

- Serum potassium, magnesium, and calcium levels within 28 days before randomization
must be within normal limits (WNL) for the lab within 28 days before randomization

- International normalized ratio of prothrombin time (INR) within 28 days before
randomization must be =< ULN for the lab; patients who are therapeutically treated
with an agent such as warfarin may participate if they are on a stable dose and no
underlying abnormality in coagulation parameters exists per medical history

- Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known
human immunodeficiency virus (HIV) disease must:

- Have a cluster of differentiation (CD)4 count >= 200 cells/uL within 30 days
before beginning study therapy

- Be off all antiretroviral therapy (prophylaxis/treatment) more than 60 days
before beginning study therapy, and

- Have no evidence of opportunistic infections

- Pregnancy test (urine or serum beta-human chorionic gonadotropin [HCG]) done within 72
hours before randomization must be negative (for women of childbearing potential
only); if urine pregnancy results are positive or cannot be confirmed as negative, a
serum pregnancy test will be required

Exclusion Criteria:

- Rectal cancer histology other than adenocarcinoma (i.e., sarcoma, lymphoma, squamous
cell carcinoma, mucosal melanoma, etc.)

- Definitive clinical or radiologic evidence of metastatic disease; required imaging
studies must have been performed within 28 days prior to randomization; Note: Distant
clinical staging to exclude patients with overt metastatic disease is determined by:

- Chest: CT scan (preferred); chest x-ray posterioranterior (PA) and lateral
(acceptable); or positron emission tomography (PET) scan (acceptable)

- Abdomen: CT scan with IV contrast (preferred); or MRI (acceptable)

- Pelvis: MRI (preferred) or CT scan with IV contrast (acceptable)

- (It is recommended that the same imaging tests that are performed before
randomization be used at follow-up time points; Note: CT scans of the
abdomen and pelvis must be performed with IV contrast)

- History of prior invasive rectal malignancy, regardless of disease-free interval

- Cardiac disease that would preclude the use of any of the drugs included in the GI002
treatment regimen; this includes but is not limited to:

- Clinically unstable cardiac disease, including unstable atrial fibrillation,
symptomatic bradycardia, unstable congestive heart failure, active myocardial
ischemia, or indwelling temporary pacemaker

- Ventricular tachycardia or supraventricular tachycardia that requires treatment
with class Ia antiarrhythmic drugs (e.g., quinidine, procainamide, disopyramide)
or class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide); use of
other antiarrhythmic drugs is permitted

- Second- or third-degree atrioventricular (AV) block unless treated with a
permanent pacemaker

- Complete left bundle branch block (LBBB)

- History of long QT syndrome

- Corrected QT (QTc) >= 450ms

- Sensory or motor neuropathy >= grade 2

- History of, or any evidence of active, non-infectious pneumonitis

- Active inflammatory bowel disease (i.e., patients requiring current medical
interventions or who are symptomatic) or have a history of abdominal surgery or other
medical condition that may, in the opinion of the treating physician, interfere with
gastrointestinal motility or absorption

- Active autoimmune disease that has required systemic treatment within the past 2 years
(i.e., with use of modifying agents, corticosteroids, or immunosuppressive drugs);
replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment

- History of active TB (Bacillus tuberculosis)

- Active or chronic infection requiring systemic therapy

- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
of immunosuppressive therapy within 7 days prior to the first dose of study therapy;
the use of physiologic doses of corticosteroids may be approved after consultation
with the study principal investigator (PI)

- Active seizure disorder uncontrolled by medication

- Any antineoplastic therapy for this cancer before randomization

- Synchronous colon cancer

- Other invasive cancer within 5 years before randomization; exceptions are colonic
polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervix

- Antineoplastic therapy (e.g. chemotherapy or targeted therapy) for other invasive
cancer within 5 years before randomization; (for the purposes of this study, hormonal
therapy is not considered chemotherapy)

- Prior treatment with an investigational compound being tested in this study (e.g.,
poly ADP ribose polymerase [PARP] inhibitor, anti-PD-1, anti-PD-L1, or anti-PD-L2)

- Receipt of live vaccination within 28 days before randomization; seasonal flu vaccines
that do not contain live virus are permitted

- Major surgery within 4 weeks before randomization

- Any therapeutic pelvic radiation

- Known homozygous DPD (dihydro pyrimidine dehydrogenase) deficiency

- Pregnant women

- Nursing women who are unwilling to discontinue nursing

- Men or women of childbearing potential who are unwilling to employ adequate
contraception (e.g., hormonal or barrier method of birth control; abstinence) for the
duration of study treatment and for 4 months after the last dose of study therapy

- Co-morbid illnesses or other concurrent disease that, in the judgement of the
clinician obtaining informed consent, would make the patient inappropriate for entry
into this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens or prevent required follow-up
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Beavercreek, Ohio 45431
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Bellevue, Washington 98004
Principal Investigator: John A. Keech
Phone: 425-688-5407
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Bellevue, WA
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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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Bemidji, MN
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Berkeley, California 94704
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Berkeley, CA
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Berlin, Vermont 05602
Principal Investigator: Christopher J. Anker
Phone: 802-225-5400
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Berlin, VT
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Billings, MT
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1233 North 30th Street
Billings, Montana 59101
406-237-7000
Principal Investigator: Keren Sturtz
Phone: 406-969-6060
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Billings, MT
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Birmingham, Alabama 35233
Principal Investigator: Andrew M. McDonald
Phone: 205-934-0220
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Birmingham, AL
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Principal Investigator: Preston D. Steen
Phone: 701-323-5760
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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Bismarck, ND
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Boise, ID
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Bolivar, Missouri 65613
Principal Investigator: Rakesh Gaur
Phone: 800-328-6010
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Bolivar, MO
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Bonne Terre, Missouri 63628
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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Bonne Terre, MO
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Osama E. Rahma
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Osama E. Rahma
Phone: 877-442-3324
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Bozeman, MT
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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
Phone: 412-339-5294
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Brainerd, MN
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Bremerton, Washington 98310
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Bremerton, WA
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Brewer, Maine 04412
Principal Investigator: Thomas H. Openshaw
Phone: 800-987-3005
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Brewer, ME
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Bridgeport, West Virginia 26330
Principal Investigator: Malcolm D. Mattes
Phone: 304-293-7374
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Bridgeport, WV
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Bronx, New York 10467
Principal Investigator: Rafi Kabarriti
Phone: 718-379-6866
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Bronx, NY
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Bronx, New York 10461
Principal Investigator: Rafi Kabarriti
Phone: 718-379-6866
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Bronx, New York 10461
Principal Investigator: Rafi Kabarriti
Phone: 718-379-6866
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30 Lawrence Road
Broomall, Pennsylvania 19008
Principal Investigator: Rachelle M. Lanciano
Phone: 610-284-8237
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Broomall, PA
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Brownstown, Michigan 48183
Principal Investigator: Eleanor M. Walker
Phone: 313-916-3721
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Brownstown, MI
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Bryan, Texas 77802
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Bryan, TX
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Burien, Washington 98166
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Burien, WA
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1501 Trousdale Drive
Burlingame, California 94010
Principal Investigator: Ari D. Baron
Phone: 650-696-4487
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Burlingame, CA
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Burlington, Vermont 05405
Principal Investigator: Christopher J. Anker
Phone: 802-656-4101
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Burlington, VT
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Burlington, Wisconsin 53105
Principal Investigator: Federico Augusto H. Sanchez
Phone: 414-302-2304
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Principal Investigator: Paul W. Sperduto
Phone: 952-993-1517
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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400 South Clark Street
Butte, Montana 59701
406-723-2500
Principal Investigator: Keren Sturtz
Phone: 406-723-2621
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
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Butte, MT
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3123 Medical Dr
Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Caldwell, ID
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Cameron Park, California 95682
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Canton, Ohio 44708
Principal Investigator: Mitchell Haut
Phone: 888-293-4673
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: Bryan A. Faller
Phone: 573-334-2230
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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