A Phase II Study of Gemcitabine, Carboplatin, and Panitumumab Given Before Surgery in Patients with Muscle-Invasive Bladder Cancer

Protocol
10-103
Full Title
Phase II Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
Phase
II
Purpose

Patients who are diagnosed with bladder cancer that has penetrated nearby muscles (“muscle-invasive bladder cancer”) undergo surgery to have the bladder removed (cystectomy). Studies have shown that patients who receive chemotherapy before this surgery (“neoadjuvant chemotherapy”) live longer than those who have the surgery alone.

Gemcitabine and carboplatin are drugs commonly used for neoadjuvant treatment of muscle-invasive bladder cancer. In this study, researchers are assessing the safety and effectiveness of adding a third drug, panitumumab, to this drug combination as neoadjuvant therapy for patients with muscle-invasive bladder cancer.

Panitumumab is approved for treating advanced colorectal cancer, but its use for bladder cancer is considered investigational. It works by binding to and blocking a protein called epidermal growth factor receptor.

Eligibility

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

  • Patients must have a confirmed diagnosis of muscle-invasive transitional cell carcinoma of the bladder and be candidates for cystectomy.
  • Patients may not have had prior systemic chemotherapy or radiation therapy for bladder cancer, although intravesicular therapy (treatment given directly into the bladder) is allowed.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Dean Bajorin at 646-422-4333.

Disease(s)
Bladder Cancer
Related Diseases