Skip to main content
OpenTrials
Completed

NCT Number: NCT01131078

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Paola, Calabria, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Avastin

Capecitabine

Drug

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

Drug

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

Primary outcomes

  1. Percentage of Participants With Disease Progression or Death

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

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

  2. Time to Progression (TTP)

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

    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.

Secondary outcomes

  1. Percentage of Participants Who Died

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

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

  2. Overall Survival

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

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

  3. Percentage of Participants With Treatment Failure

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

    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.

  4. Time to Treatment Failure

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

    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.

  5. Percentage of Participants With Progression Excluding Deaths

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

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

  6. Time to Progression Excluding Deaths

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

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

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

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

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

  8. Time to Progression Excluding Deaths Not Related to Underlying Cancer

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

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

  9. Percentage of Participants by Best Overall Response

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

    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;

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

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

    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;

  11. Percentage of Participants With Stable Disease

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

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

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

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

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

  13. Duration of Overall Response

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

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

  14. Duration of Stable Disease (SD)

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

    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.

  15. Duration of Overall Complete Response

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

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
May 26, 2010
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.