Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — BIOLOGICAL
  bevacizumab 5 mg/kg IV on day 1 every 14 days until excessive toxicity or disease progression
• fluorouracil — DRUG
  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
• leucovorin — DRUG
  leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression
• oxaliplatin — DRUG
  Oxaliplatin 85 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression

Study Details

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.

Key Dates

First listed

May 4, 2006

Start date

Mar 31, 2006

Status verified

Mar 2024

Primary completion

Nov 30, 2009

Completion

Dec 31, 2012

Study Design

Enrollment

90 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
  Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Primary Outcome Measure

Major Morbidity Related to the Intact Primary Tumor [ Time Frame: 24 months ]

Locations (163)

Find similar trials in Little Rock, AR

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