Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Disease Progression

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

Irinotecan

Capecitabine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Topoisomerase I Inhibitors

Enzyme Inhibitors

Cola

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle.

Bevacizumab [Avastin]

Capecitabine was administered orally at a doses of 1000 or 1250, mg/m\^2 twice daily (Day 2 to 15) or as 650 mg/m\^2 twice daily on Days 1 to 21.

Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks.

Clinical Trials

A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.

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

A Randomized, Open-label Study Comparing the Effect of 3 Chemotherapy Regimens Containing Avastin on Time to Disease Progression in Patients With Metastatic Colorectal Cancer

Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.

TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.

Overall survival is defined as the time from date of randomization until death from any cause

Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis.

Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent.

Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates.

The failure event was defined as tumor progression excluding deaths due to any reason.

The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis.

The failure event was defined as tumor progression excluding only deaths not related to underlying cancer.

The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. Kaplan-Meier estimates were used for analysis.

Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions;

CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions;

Stable disease rate was the proportion of participants who achieved CR, PR, or SD.

Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment.

Duration of overall response included participants who achieved a CR or PR.

Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis.

Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis.

Hoffmann-La Roche

Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)

Bevacizumab + Capecitabine (1250 mg/m^2)

Bevacizumab + Capecitabine (650 mg/m^2)

Total

Age, Continuous

Sex: Female, Male

All enrolled participants were included in the Intent-to-Treat (ITT) population.

Medical Communications

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.

Percentage of Participants With Disease Progression or Death

Percentage of Participants Who Died

ITT Population; Only participants with an event (death) were included in the analysis.

Overall Survival

Percentage of Participants With Treatment Failure

ITT Population; only participants with a treatment failure event were included in the analysis.

Time to Treatment Failure

Percentage of Participants With Progression Excluding Deaths

ITT Population; Only participants with a time to progression event (excluding deaths) were included in the analysis.

Time to Progression Excluding Deaths

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal..

Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer

ITT Population; only participants with a time to progression event (excluding deaths not related to underlying cancer) were included in the analysis.

Time to Progression Excluding Deaths Not Related to Underlying Cancer

ITT Population; only those participants with an event of disease progression or death were included in the analysis

Time to Progression (TTP)

ITT Population; All participants with evaluable data were included in the analysis

Percentage of Participants by Best Overall Response

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

Percentage of Participants With Stable Disease

ITT Population; All participants with evaluable data were included in the analysis.

Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment

ITT Population; only participants with a best overall response of CR or PR were included in the analysis.

Duration of Overall Response

ITT Population; Only participants with a best overall response of CR, PR, or SD were included in the analysis.

Duration of Stable Disease (SD)

ITT Population; Only participants with a best overall response were included in the analysis.

Duration of Overall Complete Response

Bevacizumab was administered as a 7.5 milligrams per kilogram (mg/kg) intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 milligrams per meter squared (mg/m\^2) intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or stable disease (SD) were treated with bevacizumab alone until unacceptable toxicity, progressive disease (PD), or participant withdrawal.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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