RATIONALE: Bevacizumab may stop the growth of breast cancer by stopping blood flow to the tumor.

PURPOSE: Clinical trial to study the effectiveness of bevacizumab in treating patients who have previously received bevacizumab for metastatic breast or colorectal cancer.

Condition	Treatment or Intervention
stage IV breast cancer recurrent breast cancer stage IV colon cancer Stage IV rectal cancer	Drug: bevacizumab  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: antibody therapy  Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy  Procedure: monoclonal antibody therapy

OBJECTIVES:

• Provide an extension of bevacizumab treatment to patients with metastatic breast or colorectal cancer who received this drug in a prior phase II or III Genentech-sponsored clinical trial.
• Determine the safety of long-term administration of this drug in these patients.

OUTLINE: This is an open-label, multicenter, extension study.

Patients receive bevacizumab IV over 30-90 minutes every 2 or 3 weeks according to the original Genentech treatment schedule. Treatment continues for 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 4 months for 1 year.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic breast or colorectal cancer
• Must have received bevacizumab on, and completed participation in, 1 of the following Genentech-sponsored phase II or III clinical trials (less than 3 months since last dose):
• GENENTECH-AVF2107g*
• GENENTECH-AVF2119g*
• GENENTECH-AVF2192g* NOTE: *Patients who were randomized to the control arms of these studies are ineligible
• No primary brain tumor or brain metastases
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age

• 18 and over

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 75,000/mm^3
• Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed)
• No bleeding diathesis or coagulopathy

Hepatic

• No compromised hepatic function
• INR less than 1.5 (unless approved to receive concurrent full-dose warfarin)
• Bilirubin no greater than 2.0 mg/dL (1.6 mg/dL for patients receiving irinotecan)
• AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with documented liver metastases)

Renal

• No compromised renal function
• No proteinuria OR
• Proteinuria less than 2 g by 24-hour urine collection
• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No clinically significant cardiovascular disease
• No uncontrolled hypertension (blood pressure greater than 160/110 mm Hg on medication)
• No prior myocardial infarction
• No prior stroke
• No unstable angina
• No New York Heart Association grade II-IV congestive heart failure
• No serious cardiac dysrhythmia requiring medication
• No grade II or greater peripheral vascular disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3-6 months after study participation
• No significant traumatic injury within the past 28 days
• No seizures uncontrolled with standard medical therapy
• No history or physical evidence of other CNS disease
• No other disease that would preclude study participation
• No metabolic dysfunction
• No physical examination or clinical laboratory finding that would preclude study participation
• No unresolved or irreversible bevacizumab-related ongoing serious adverse event from prior participation in the Genentech-sponsored phase II or III study
• No serious, nonhealing wound, ulcer, or bone fracture

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• More than 28 days since prior major surgical procedure or open biopsy
• More than 7 days since prior fine needle aspirations or core biopsies
• No anticipated need for a major surgical procedure during study therapy

Other

• More than 4 weeks since prior participation in other experimental drug studies (except Genentech-sponsored bevacizumab cancer studies)
• No concurrent participation in another experimental drug study
• No concurrent chronic daily aspirin greater than 325 mg/day
• No concurrent nonsteroidal anti-inflammatory medications that would inhibit platelet function in order to treat chronic inflammatory diseases
• No concurrent full-dose warfarin unless approved by the investigator
• No concurrent full-dose heparin
• No concurrent thrombolytic agents

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting

Study chairs or principal investigators

Fairooz F. Kabbinavar, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000316265; UCLA-0212064; GENENTECH-AVF2540g
Record last reviewed:  July 2003
Record first received:  August 6, 2003
ClinicalTrials.gov Identifier:  NCT00066560
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-05