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

NCT00114946 | Terminated Phase 4

• 1 other identifier: AVF3430n
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Keywords

Metastatic Colorectal Cancer OASIS

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

Avastin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mary Sugrue, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 20, 2005
• First Posted: June 21, 2005
• Study Start: May 1, 2005
• Study Completion: December 1, 2007
• Last Updated: May 29, 2006

Record last verified: 2006-05