A Study to Compare Two Avastin-Based Treatment Regimens for the Treatment of Metastatic Colorectal Cancer

May 26, 2006 updated by: Genentech, Inc.

A Randomized, Open-Label Trial Comparing Two Avastin (Bevacizumab)-Based Treatment Regimens for the First-Line Treatment of Metastatic Colorectal Cancer

This is a randomized, open-label, active-control, multicenter trial comparing two oxaliplatin/Avastin-based treatment sequences as first-line therapy for metastatic colorectal cancer. The study is designed to compare the efficacy of these two treatment sequences with respect to progression free survival (PFS) and overall survival.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

800

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed Informed Consent Form
  • Metastatic or locally advanced and unresectable colorectal cancer
  • Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
  • Age >= 18 years
  • ECOG performance status of 0 or 1
  • Adequate hematologic, hepatic, and renal function at the time of study entry to begin prescribed study therapy, according to institutional guidelines
  • Use of an effective form of contraception during the study (for subjects of childbearing potential and their partners)

Exclusion Criteria:

  • Prior treatment with Avastin
  • Hypersensitivity to any of the study drugs or ingredients
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
  • History of any other malignancy (except squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that has been effectively treated) unless in complete remission and off all therapy for that malignancy for at least 5 years
  • Known brain or central nervous system metastases
  • Prior treatment for advanced or metastatic colorectal cancer
  • Prior treatment with an anti-angiogenesis agent, in either the adjuvant or metastatic setting
  • Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrollment)
  • Medical or psychiatric disorders that would interfere with informed consent or compliance, or would render the subject at high risk for participation in this study and its follow-up procedures
  • Active infection requiring antibiotics on Day 1
  • New York Heart Association (NYHA) Grade II or greater CHF
  • Evidence of bleeding diathesis or coagulopathy
  • Grade > 1 peripheral neuropathy (as defined by the NCI CTCAE, v3.0)
  • Lack of physical integrity of the upper gastrointestinal tract or history of malabsorption syndrome
  • Blood pressure > 150/100 mmHg
  • Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1; anticipation of need for a major surgical procedure during the course of the study
  • Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 1
  • Urine protein:creatinine ratio >= 1.0 at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
  • Serious, non-healing wound, ulcer, or bone fracture
  • History of myocardial infarction within 6 months prior to Day 1
  • Unstable angina
  • Clinically significant peripheral vascular disease
  • History of stroke within 6 months prior to Day 1
  • Pregnancy (positive pregnancy test) or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the efficacy, as measured by progression-free survival (PFS), of FOLFOX/Avastin followed by FOLFIRI/Avastin versus FOLFOX/Avastin followed by 5-FU/LV/Avastin as first-line therapy for previously untreated metastatic colorectal cancer.

Secondary Outcome Measures

Outcome Measure
To evaluate the tolerability of sequential treatment in subjects and to evaluate the safety of an irinotecan/Avastin-based regimen versus a 5-FU/Avastin regimen for previously untreated metastatic colorectal cancer.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Mary Sugrue, M.D., Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

June 20, 2005

First Submitted That Met QC Criteria

June 20, 2005

First Posted (Estimate)

June 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 29, 2006

Last Update Submitted That Met QC Criteria

May 26, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVF3430n

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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