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Efficacy and Safety Study of rhuMAb VEGF to Treat Metastatic Renal Cell Carcinoma

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. Identifier: NCT00061178
Recruitment Status : Withdrawn (No patients were enrolled, study cancelled before start)
First Posted : May 23, 2003
Last Update Posted : October 19, 2016
Information provided by:
Genentech, Inc.

Brief Summary:
The purpose of this study is to determine whether rhuMAb VEGF (Bevacizumab) is safe and effective for the treatment of renal cell cancer when other treatments have failed.

Condition or disease Intervention/treatment Phase
Renal Cell Cancer Drug: rhuMAb VEGF (Bevacizumab) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy & Safety of rhuMAb VEGF in Previously Treated Metastatic Renal Cell Carcinoma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Histologically confirmed, metastatic renal cell cancer (RCC) of clear cell histology
  • Clinical or radiographic evidence of disease progression (as assessed by the investigator and reviewed by the Sponsor) during or after completion of one, and only one, cytokine-based regimen for metastatic disease
  • At least 21 days since any prior therapy for RCC
  • Prior nephrectomy
  • Use of an acceptable means of contraception (potentially fertile men and women)
  • ECOG performance status of 0 or 1
  • Life expectancy >= 3 months
  • Age 18 years or older

Exclusion Criteria:

  • RCC of papillary or collecting-duct type
  • More than one nonsurgical therapy for metastatic RCC (note that medroxyprogesterone acetate not used for physiologic replacement or birth control is considered a therapy for RCC for the purposes of this study)
  • Prior treatment with thalidomide
  • Radiotherapy within 14 days of Day 0
  • Current, recent (within 21 days of Day 0), or planned participation in an experimental drug study
  • Pregnant or breast-feeding subjects
  • Any of the following screening clinical laboratory values: 24-hour urine collection with >= 1 g of protein; Serum creatinine > 2.0 mg/dL; Absolute neutrophil count (ANC) <500/mL; Platelet count <75,000/mL; INR >= 1.5; Total bilirubin > 2.0 mg/dL; AST or ALT > 5 x the upper limit of normal (ULN) for subjects with documented liver metastases or > 2.5 x the ULN for subjects without evidence of liver metastases; Hemoglobin < 9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level)
  • Other invasive malignancies within 5 years of randomization (other than squamous or basal cell carcinoma of the skin)
  • 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
  • Inability to comply with study and/or follow-up procedures

Layout table for additonal information Identifier: NCT00061178    
Other Study ID Numbers: AVF2665g
First Posted: May 23, 2003    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors