A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

Roche

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181609

ML18559

Details and patient eligibility

About

This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
• Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.

Exclusion criteria

• Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
• Untreated brain metastases, spinal cord compression or primary brain tumours;
• Pregnant or lactating women;
• 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

1

Experimental group

Treatment:

Drug: bevacizumab [Avastin]