A Study to Evaluate Avastin in Patients Treated in a Previous Genentech-Sponsored Cancer Study

NCT00096967 | Completed Phase 3

• 1 other identifier: AVF2540g
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, open-label extension study. Subjects who have received rhuMAb VEGF therapy in Study AVF2107g, AVF2119g, or AVF2192g and who completed the parent study are eligible for inclusion in this trial. Subjects who have received placebo in Study AVF2107g or AVF2192g are also eligible.

Conditions

Breast Cancer; Colorectal Cancer; Metastases

Keywords

Metastatic breast cancer; Metastatic colorectal cancer

Interventions

Avastin (bevacizumab) DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Previous participation in and completion of one of the following Genentech-sponsored rhuMAb VEGF Phase II or Phase III cancer studies: AVF2107g, AVF2119g, or AVF2192g
• Use of an effective means of contraception in men and in women of childbearing potential
• For subjects who received placebo in the parent study, current antitumor therapy not exceeding third-line treatment for disease progression

You may not qualify if:

• Compromised renal or hepatic function, as defined in the parent protocol
• EGOG status of 3 or greater
• 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 rhuMAb VEGF cancer study
• ANC of \<1500/uL
• Platelet count of \<75,000/uL
• International normalized ration (INR) \>=1.5 (except those subjects who have been given approval to receive full-dose warfarin plus rhuMAb VEGF)
• Total bilirubin of \>1.6 mg/dL for patients receiving irinotecan, for all others total bilirubin of \>2.0 mg/dL
• AST or ALT \>5 times upper limit of normal for subjects with documented liver metastases; \>2.5 times the upper limit of normal for subjects without evidence of liver metastases
• Serum creatinine of \>2.0 mg/dL
• Hemoglobin of \<9 gm/dL (may be transfused or receive epoetin alfa \[e.g., Epogen\] to maintain or exceed this level)
• Inability to comply with study and/or follow-up procedures
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
• Any unresolved or irreversible rhuMAb VEGF-related ongoing serious adverse event occurring during the parent study
• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension \[blood pressure of \>160/110 mmHg on medication\], previous myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (Grade II or greater)
• History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2004
• First Posted: November 18, 2004
• Study Start: October 1, 2002
• Study Completion: July 1, 2004
• Last Updated: March 26, 2014

Record last verified: 2014-03