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

Hoffmann-La Roche306 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

306

Conditions

Colorectal Cancer

Interventions

Bevacizumab [Avastin]DRUG

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

CapecitabineDRUG

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.

IrinotecanDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients \>=18 years of age; * colon or rectal cancer, with metastases; * \>=1 measurable lesion. Exclusion Criteria: * previous systemic treatment for advanced disease; * radiotherapy to any site within 4 weeks before study; * daily aspirin (\>325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration; * co-existing malignancies or malignancies diagnosed within last 5 years (except basal cell cancer or cervical cancer in situ).

Locations (44)

Outcomes

Primary Outcomes

Percentage of Participants With Disease Progression or Death

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

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Time to Progression (TTP)

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.

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Secondary Outcomes

Percentage of Participants Who Died

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

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Overall Survival

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

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Percentage of Participants With Treatment Failure

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 frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Time to Treatment Failure

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.

Data from ClinicalTrials.gov

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Unnamed facility

Paola, Calabria, Italy

Unnamed facility

Benevento, Campania, Italy

Unnamed facility

Naples, Campania, Italy

Unnamed facility

Bologna, Emilia-Romagna, Italy

Unnamed facility

Carpi, Emilia-Romagna, Italy

Unnamed facility

Piacenza, Emilia-Romagna, Italy

Unnamed facility

Latisana, Friuli Venezia Giulia, Italy

Unnamed facility

Udine, Friuli Venezia Giulia, Italy

Unnamed facility

Latina, Lazio, Italy

Unnamed facility

Rome, Lazio, Italy

...and 34 more locations

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Percentage of Participants With Progression Excluding Deaths

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

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Time to Progression Excluding Deaths

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

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

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

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

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Time to Progression Excluding 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.

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Percentage of Participants by Best Overall Response

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;

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

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

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;

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Percentage of Participants With Stable Disease

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

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

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

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

Time frame: Randomization, Weeks 3, 6 and 9, and 12

Duration of Overall Response

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

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Duration of Stable Disease (SD)

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.

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Duration of Overall Complete Response

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.

Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years