Title (CALGB 90601) A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin and Bevacizumab to Gemcitabine, Cisplatin and Placebo in Patients with Advanced Transitional Cell Carcinoma
Principal Investigator Roberto Pili, MD
Study Number 186610
Summary The purpose of this study is to compare the effects of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin and the experimental drug bevacizumab on transitional cell cancer.
- Patients must have documented metastatic or unresectable transitional cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate or urethra) with progressive metastatic or locally advanced disease. Patients must not be candidates for potentially curative surgery or radiotherapy.
- Patients may not have received combination systemic chemotherapy for metastatic disease.
- For the purpose of this study, radiosensitizing single agent chemotherapy is not considered prior systmeic therapy.
- Prior neoadjuvant or adjuvant systemic chemotherapy is permissible provided the interval from end of therapy to diagnosis of metastatic disease is at least 1 year.
- Greater than or equal to 4 weeks since any prior radiation (including palliative) or major surgery and fully recovered.
- >= 7 days since any minor surgery such as port placement.
- Greater than or equal to 4 weeks since any intravesical therapy
- No prior treatment with bevacizumab or other angiogenesis inhibitors.
- No known brain metastases.
- Patients who are pregnant or nursing are not eligible.
- For women of child-bearing potential with an elevated beta-HCG that is believed to be related to cancer and not pregnancy, a negative trans-vaginal ultrasound and gynecological examination are required.