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An Open-Label, Multicenter Extension Study of rhuMAb VEGF (Bevacizumab) in Subjects Treated in a Previous Genentech-Sponsored Cancer Study

Phase 3
Not Enrolling
Breast Cancer, Colorectal Cancer, Metastases

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Trial Information

An Open-Label, Multicenter Extension Study of rhuMAb VEGF (Bevacizumab) in Subjects Treated in a Previous Genentech-Sponsored Cancer Study

Inclusion Criteria:

- 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

- For subjects who received placebo in the parent study, current antitumor therapy not
exceeding third-line treatment for disease progression

Exclusion Criteria:

- 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)

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, or anticipation of need for major surgical procedure during the
course of the study

- Fine needle aspirations or core biopsies within 7 days prior to Day 0

- Chronic, daily treatment with aspirin (>325 mg/day) or nonsteroidal anti inflammatory
medications (of the kind known to inhibit platelet function at doses used to treat
chronic inflammatory diseases)

- Pregnancy (positive pregnancy test) or lactation

- Proteinuria at baseline or clinically significant impairment of renal function

- Serious, nonhealing wound, ulcer, or bone fracture

- Evidence of bleeding diathesis or coagulopathy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

October 2002

Completion Date:

July 2004

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Metastases
  • Metastatic breast cancer
  • Metastatic colorectal cancer
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis