Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer adenocarcinoma of the rectum recurrent rectal cancer stage IV rectal cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine, 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 find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the response rate in patients with previously untreated metastatic colorectal cancer treated with capecitabine, oxaliplatin, and bevacizumab.

Secondary

* Assess time to progression (TTP), disease-free survival (DFS), and overall survival (OS) in patients treated with this regimen.
* Assess the safety and tolerability of bevacizumab, oxaliplatin, and capecitabine in patients with previously untreated metastatic colorectal cancer.

Exploratory

* Evaluate the effect of this regimen on the biomarkers of angiogenesis.
* Assess the effect of this regimen on wound angiogenesis.

OUTLINE: Patients receive oral capecitabine twice daily on days 1-5 and 8-12, oxaliplatin IV over 2 hours on day 1, and bevacizumab IV over 1-1½ hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: bevacizumab intervention 2: oxaliplatin intervention 3: Capecitabine intervention 4: Capecitabine
Intervention descriptions: intervention 1: 10 mg/kg intravenously over 30-90 minutes on day 1 intervention 2: 85 mg/m2 intravenously over 2 hours on day 1. intervention 3: Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort intervention 4: Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Protocol document: