A Phase III Study of Gemcitabine and Cisplatin with and without Bevacizumab in Patients with Advanced Transitional Cell Carcinoma

Protocol
12-119
Full Title
A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma (CALGB 90601)
Phase
III
Purpose

The standard treatment for transitional cell carcinoma (a cancer of the bladder, ureter, urethra, or kidney) includes the drugs gemcitabine and cisplatin. In this study, researchers want to know if adding the drug bevacizumab to this regimen can help patients with inoperable or metastatic transitional cell carcinoma live longer.

Bevacizumab is already approved for treating advanced cancers of the colon, brain, kidney (renal cell), and lung, but its use for transitional cell cancers is considered investigational. It inhibits the development of the blood vessels that tumors need to grow and spread by blocking a protein called VEGF.

Patients in this study will be randomly assigned to receive gemcitabine/cisplatin/bevacizumab or gemcitabine/cisplatin/placebo.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced transitional cell carcinoma that cannot be removed surgically or has spread to other parts of the body.
  • Patients may have received prior treatment, but no chemotherapy for metastatic disease. At least a year must have passed between completion of prior perioperative chemotherapy and the diagnosis of metastatic disease.
  • At least 4 weeks must have passed since radiation therapy or intravesical therapy and entry into the study.
  • Patients may not have had prior treatment with bevacizumab or other drugs that inhibit blood vessel formation.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Jonathan Rosenberg at 646-422-4461.