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 4

Conditions: Colorectal Cancer

Treatments: Drug: Irinotecan; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: 5-Fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02582970

ML18436

Details and patient eligibility

About

This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously untreated metastatic colon or rectal cancer
• Scheduled to begin IV 5-fluorouracil-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 prior to study start
• Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Bevacizumab + Chemotherapy

Experimental group

Description:

Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.

Treatment:

Drug: Irinotecan

Drug: Bevacizumab

Drug: 5-Fluorouracil

Drug: Oxaliplatin