A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.

Roche

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: Fluoropyrimidine-based Chemotherapy; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01169558

ML20552

Details and patient eligibility

About

This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously untreated metastatic colon or rectal cancer;
• Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.

Exclusion criteria

• Prior chemotherapy for metastatic colon or rectal cancer;
• Planned radiotherapy for underlying disease;
• central nervous system metastases;
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

Bevacizumab

Experimental group

Description:

Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.

Treatment:

Drug: Bevacizumab

Drug: Fluoropyrimidine-based Chemotherapy