Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer

Conditions

• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IVA Colon Cancer
• Stage IVA Rectal Cancer
• Stage IVB Colon Cancer
• Stage IVB Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cetuximab — BIOLOGICAL
  Given IV
• bevacizumab — BIOLOGICAL
  Given IV
• irinotecan hydrochloride — DRUG
  Given IV
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

This randomized phase II trial is studying giving bevacizumab and cetuximab together with irinotecan to see how well it works compared to giving bevacizumab and cetuximab alone in treating patients with irinotecan-refractory metastatic colorectal cancer. Monoclonal antibodies such as cetuximab and 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 deliver tumor -killing substances to them. Drugs used in chemotherapy, such as irinotecan, also work in different ways to kill tumor cells or stop them from growing. Giving cetuximab and bevacizumab together with irinotecan may improve the ability to block tumor growth.

Key Dates

Start date

Dec 31, 2003

Status verified

Dec 2012

Primary completion

Jul 31, 2007

Completion

Jul 31, 2007

Study Design

Enrollment

70 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (cetuximab, bevacizumab, irinotecan)I
  Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36; bevacizumab IV over 30-90 minutes on days 1\*, 15, and 29 OR on days 1 and 22; and irinotecan IV over 30-90 minutes (at the same dose and schedule that the patient previously received) beginning on day 1. NOTE: \*Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses.
• Experimental: Arm B (cetuximab and bevacizumab)
  Patients receive cetuximab as in Arm A and bevacizumab IV over 30-90 minutes on days 1\*, 15, and 29. NOTE: \*Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses.

Primary Outcome Measure

Time to tumor progression [ Time Frame: Date of randomization to the date of either documentation of disease progression, or death, assessed up to 3 years ]

Locations (1)

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