Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer



Status:Active, not recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:August 4, 2005

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A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin Versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and
bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and
fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs
used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, 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. Monoclonal antibodies, such as
bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet
known whether giving combination chemotherapy together with bevacizumab is more effective
than combination chemotherapy alone in treating colon cancer.

PRIMARY OBJECTIVES:

I. To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon
cancer patients randomly assigned to 5-FU (fluorouracil), leucovorin (leucovorin calcium),
oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab.

SECONDARY OBJECTIVES:

I. To compare overall survival between the regimens. II. To further define the toxicity
profiles of the regimens. III. To prospectively determine the impact of tumor biological
characteristics on the survival of patients with stage II colon cancer.

IV. To assess the association between oxaliplatin exposure, allelic variants in candidate
genes, and neurotoxicity. (Pharmacogenetic ancillary objective)

OUTLINE: Patients with high-risk disease are randomized to 1 of 2 treatment arms (Arms A and
B). Patients with low-risk disease are assigned to Arm C.

ARM A: Patients receive oxaliplatin intravenously (IV) over 2 hours and leucovorin calcium IV
over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours
beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease
progression or unacceptable toxicity.

ARM B: Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and
bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in
the absence of disease progression or unacceptable toxicity. Patients then receive
bevacizumab alone for 12 additional courses in the absence of disease progression or
unacceptable toxicity.

ARM C: Patients undergo observation.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then every 12 months for 10 years.

Inclusion Criteria:

- STEP 1: INITIAL REGISTRATION

- The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if
this distance was not confirmed on endoscopy pre-operatively, then the distal extent
of the tumor must be >= 12 cm from the anal verge as determined by surgical
examination; colonoscopy should be performed postoperatively for those unable to have
a preoperative colonoscopy to guarantee there are no synchronous lesions; (if tumor is
located beyond sigmoid colon and centimeter distance unavailable, include anatomic
region of colon, e.g. right colon, transverse colon, hepatic flexure descending colon,
cecum etc.)

- Patients must have paraffin-embedded tumor specimen available for evaluation of
microsatellite instability and loss of heterozygosity at 18q, to determine high risk
versus low risk

- High-risk patients will be randomized to treatment Arms A or B

- Low-risk patients will be registered to Arm C for observation

- NOTE: Every effort should be made to submit blocks (tumor and normal mucosa)
to the Principal Coordinates Analysis (PCO) immediately; blocks CANNOT be
accepted after day 50 (post surgery) in order to allow for molecular
assessment

- Specific laboratory requirements for Step 2 must be obtained within 2 weeks
prior to Step 2 randomization

- Patients must not have synchronous tumors

- Patients must not have appendiceal tumors

- Patients must not have a history of inflammatory bowel disease (IBD)

- Patients with hereditary non-polyposis colorectal cancer (HNPCC) are eligible

- Patients must have no history of isolated, distant, or non-contiguous intra-abdominal
metastases, even if restricted

- Patients must have histologically confirmed adenocarcinoma of the colon that meets the
criteria below:

- Stage II adenocarcinoma (pT3/pT4a/pT4b pN0 M0 according to the definitions of the
American Joint Committee on Cancer, 7th Edition, 2010): the tumor invades through
the muscularis propria into pericolic tissues (pT3), penetrates to the surface of
the visceral peritoneum (pT4a), or directly invades other organs or structures
(pT4b); patients with mesenteric tumor deposits or satellites without
identifiable residual lymph node in the absence of lymph node involvement are now
designated pN1c, rather than pT3; patients with such tumor deposits are not
eligible for E5202; patients must have had a complete resection (R0 resection)

- Patients must have >= 8 lymph nodes evaluated and reported

- Patients must not have presented with clinical complete obstruction or perforation of
the bowel

- Patients must not have had any systemic or radiation therapy initiated for this
malignancy

- Patients must not have a previous or concurrent malignancy; exceptions are made for
patients who meet any of the following conditions:

- Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ

- Prior malignancy completely excised or removed and patient has been continuously
disease free for > 5 years

- Patients with completely excised or removed breast cancer and disease free > 5
years, regardless of the continuation of hormonal therapy

- Patients with previous radiation therapy (RT) to the pelvic region will be
ineligible

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- STEP 2: RANDOMIZATION (HIGH RISK PATIENTS - ARMS A AND B ONLY)

- Within 2 weeks prior to randomization, postoperative absolute granulocyte count (AGC)
must be >= 1500/mm^3 (or < 1500/mm^3, if in the opinion of the investigator, this
represents an ethnic or racial variation of normal)

- Within 2 weeks prior to randomization, the postoperative platelet count must be >=
100,000/mm^3

- Within 2 weeks prior to randomization, there must be postoperative evidence of
adequate hepatic function; bilirubin must be =< upper limit of normal (ULN) unless the
patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar
syndrome due to slow conjugation of bilirubin

- Within 2 weeks prior to randomization, there must be postoperative evidence of
adequate hepatic function; alkaline phosphatase must be < 2.5 x ULN

- Within 2 weeks prior to randomization, there must be postoperative evidence of
adequate hepatic function; aspartate transaminase (AST) must be < 1.5 x ULN

- Within 2 weeks prior to randomization, there must be postoperative evidence of
adequate renal function; serum creatinine =< 1.5 x ULN

- Within 2 weeks prior to randomization, there must be postoperative evidence of
adequate renal function; urine protein/creatinine (UPC) ratio of < 1.0; patients with
a UPC ratio >= 1.0 must undergo a 24-hour urine collection, which must be an adequate
collection and must demonstrate < 1 gm of protein in order to participate

- Patients with any significant bleeding that is not related to the primary colon tumor
within 6 months prior to study entry are not eligible

- Patients with gastroduodenal ulcer(s) determined to be active by endoscopy are not
eligible

- Patients with a history of hypertension must measure < 150/90 mmHg and be on a stable
regimen of anti-hypertensive therapy

- Patients must not have a serious or non-healing wound, skin ulcers or bone fracture

- Patients experiencing clinically significant peripheral neuropathy at the time of step
2 randomization (defined in the National Cancer Institute [NCI] Common Terminology
Criteria for Adverse Events version 4.0 [CTCAE 4.0] as grade 2 or greater neurosensory
or neuromotor toxicity) are not eligible

- Patients must not have had invasive procedures, defined as follows:

- Major surgical procedure, open biopsy or significant traumatic injury within 28
days prior to randomization

- Core biopsy or other minor procedure, excluding placement of a vascular access
device, within 7 days prior to randomization

- Or anticipate the need for major surgical procedure(s) during the course of the
study

- Patients must begin adjuvant treatment no less than 28 days and no more than 60 days
from surgery

- Eligible patients of reproductive potential (both sexes) must agree to use an accepted
and effective method of contraceptive during study therapy and for at least 3 months
after the completion of bevacizumab; women must not be pregnant or breast-feeding; all
females of childbearing potential must have a serum pregnancy test to rule out
pregnancy within 2 weeks prior to step 2 randomization

- Patients with prothrombin time (PT) (international normalized ratio [INR]) > 1.5 are
not eligible, unless the patient is on full-dose anticoagulants; if so, the following
criteria must be met for enrollment:

- The subject must have an in-range INR (usually between 2 and 3) on a stable dose
of warfarin or on a stable dose of low molecular weight heparin

- The subject must not have active bleeding or a pathological condition that is
associated with a high risk of bleeding

- Patients with non-malignant systemic disease (cardiovascular, renal, hepatic, etc.)
that would preclude any of the study therapy drugs are not eligible; specifically
excluded are the following conditions:

- New York Heart Association (NYHA) class III or IV congestive heart failure

- Current symptomatic arrhythmia

- Any non-malignant systemic disease

- Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident
(CVA) are not eligible

- Patients with a history of the following within twelve months of study entry are not
eligible:

- Arterial thromboembolic events

- Unstable angina

- Myocardial infarction

- Patients with symptomatic peripheral vascular disease are not eligible

- Patients with psychiatric or addictive disorders or other conditions that, in the
opinion of the investigator, would preclude them from meeting the study requirements
are not eligible

- Patients must not have a known allergy to platinum compounds

- STEP 2: REGISTRATION (LOW-RISK PATIENTS - ARM C)

- Patients determined to be low risk are eligible
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