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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131078
• Other study ID #: ML18524
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2010
• Last updated: June 2, 2015
• Start date: June 2005
• Est. completion date: November 2012

Study information

• Verified date: June 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: ITALY: Agenzia Italiana del Farmaco
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Bevacizumab [Avastin]
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle.
• Capecitabine
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
Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Disease Progression or Death	Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Primary	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.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	Percentage of Participants Who Died	Overall survival is defined as the time from date of randomization until death from any cause	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	Percentage of Participants With Progression Excluding Deaths	The failure event was defined as tumor progression excluding deaths due to any reason.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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;	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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;	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	Percentage of Participants With Stable Disease	Stable disease rate was the proportion of participants who achieved CR, PR, or SD.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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.	Randomization, Weeks 3, 6 and 9, and 12	No
Secondary	Duration of Overall Response	Duration of overall response included participants who achieved a CR or PR.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death	No
Secondary	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.	Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years	No