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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00096967
First Posted: November 18, 2004
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition Intervention Phase
Breast Cancer Colorectal Cancer Metastases Drug: Avastin (bevacizumab) Phase 3

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Extension Study of rhuMAb VEGF (Bevacizumab) in Subjects Treated in a Previous Genentech-Sponsored Cancer Study

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Estimated Enrollment: 100
Study Start Date: October 2002
Study Completion Date: July 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 potential
  • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00096967     History of Changes
Obsolete Identifiers: NCT00066560
Other Study ID Numbers: AVF2540g
First Submitted: November 17, 2004
First Posted: November 18, 2004
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Genentech, Inc.:
Metastatic breast cancer
Metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents