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

Genentech

Status and phase

Withdrawn

Phase 3

Conditions

Renal Cell Cancer

Treatments

Drug: rhuMAb VEGF (Bevacizumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00061178

AVF2665g

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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