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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00114946
Recruitment Status : Terminated
First Posted : June 21, 2005
Last Update Posted : May 29, 2006
Information provided by:
Genentech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Avastin Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Trial Comparing Two Avastin (Bevacizumab)-Based Treatment Regimens for the First-Line Treatment of Metastatic Colorectal Cancer
Study Start Date : May 2005
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00114946

Sponsors and Collaborators
Genentech, Inc.
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Study Director: Mary Sugrue, M.D. Genentech, Inc.

Layout table for additonal information Identifier: NCT00114946     History of Changes
Other Study ID Numbers: AVF3430n
First Posted: June 21, 2005    Key Record Dates
Last Update Posted: May 29, 2006
Last Verified: May 2006
Keywords provided by Genentech, Inc.:
Metastatic Colorectal Cancer OASIS
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors