Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon stage IV colon cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 90
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colon cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Determine the rate of major morbidity in patients with unresectable stage IV colon cancer and a synchronous asymptomatic primary tumor treated with fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX6) in combination with bevacizumab without resection of the primary tumor.

Secondary

* Determine the rate of specific events related to the intact primary tumor requiring hospitalization or a major intervention but not requiring surgery.
* Determine the rate of ≥ grade 3 toxicity as defined by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) that is related to study therapy prior to disease progression.
* Determine overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV given concurrently with leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years after study entry.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Arms:
arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Interventions: intervention 1: bevacizumab intervention 2: fluorouracil intervention 3: leucovorin intervention 4: oxaliplatin
Intervention descriptions: intervention 1: bevacizumab 5 mg/kg IV on day 1 every 14 days until excessive toxicity or disease progression intervention 2: 5-FU 400 mg/m2 IV bolus over 2-4 minutes then 2400 mg/m2 IV continuous infusion over 46 hours on day 1 every 14 days until excessive toxicity or disease progression intervention 3: leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression intervention 4: Oxaliplatin 85 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression

Protocol document: