Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0212064 GENENTECH-AVF2540g, NCT00066560

Objectives

1. 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.
2. Determine the safety of long-term administration of this drug in these patients.

Entry 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

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

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/mm³
• Platelet count at least 75,000/mm³
• 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

Expected Enrollment

Approximately 100 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Fairooz Kabbinavar, MD, Principal investigator		Ph: 310-206-3921; 888-798-0719

Related Information

PDQ® clinical trial GENENTECH-AVF2192g
PDQ® clinical trial GENENTECH-AVF2119g
PDQ® clinical trial GENENTECH-AVF2107g

Registry Information
Official Title		An Open-Label, Multicenter Extension Study of rhuMAb VEGF (Bevacizumab) in Subjects Treated with rhuMAb VEGF in a Previous Genentech-Sponsored Phase II or Phase III Cancer Study
Trial Start Date		2003-04-12
Registered in ClinicalTrials.gov		NCT00066560
Date Submitted to PDQ		2003-06-18
Information Last Verified		2005-02-11
NCI Grant/Contract Number		P30-CA16042

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