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

Hoffmann-La Roche54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

bevacizumab [Avastin]DRUG

5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Unnamed facility

Angers, France

Unnamed facility

Besançon, France

Unnamed facility

Boulogne-Billancourt, France

Outcomes

Primary Outcomes

Percentage of Participants Achieving Overall Disease Control (ODC)

ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.

Time frame: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)

Secondary Outcomes

Percentage of Participants Achieving a Best Overall Response of CR or PR

Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.

Time frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)

Progression-Free Survival (PFS) - Percentage of Participants With an Event

PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.

Time frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)

PFS - Time to Event

Data from ClinicalTrials.gov

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