Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Cola

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

bevacizumab [Avastin]

Clinical Trials

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.

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

An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer

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.

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.

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.

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. Median PFS was estimed using the Kaplan-Meier method.

Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.

ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.

Overall survival was defined as the time from start of study treatment to death from any cause.

OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.

Hoffmann-La Roche

All participants who received at least 1 dose of study treatment were included in the safety analysis population.

Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.

Bevacizumab + Chemotherapy

Age, Continuous

Sex: Female, Male

Intent-to-treat (ITT) population: included participants who received at least 1 dose of treatment.

Medical Communications

Percentage of Participants Achieving Overall Disease Control (ODC)

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

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

PFS - Time to Event

ITT population; only participants with a response (CR or PR) were included in the analysis.

Duration of Response

ITT population; only participants with an ODC response (CR, PR, or SD) were included in the analysis.

Duration of Overall Disease Control

Overall Survival (OS) - Percentage of Participants With an Event

OS - Time to Event

Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial