A Phase II Study of Paclitaxel/Ifosfamide/Cisplatin versus Bleomycin/Etoposide/Cisplatin in Patients Newly Diagnosed with Advanced Germ Cell Tumors

Protocol
13-074
Full Title
Randomized Phase II Trial of Paclitaxel, Ifosfamide and Cisplatin (TIP) vs. Bleomycin, Etoposide and Cisplatin (BEP) for Patients with Previously Untreated Intermediate- and Poor-Risk Germ Cell Tumors
Phase
II
Purpose

Treatment with the chemotherapy drugs bleomycin, etoposide, and cisplatin is the standard therapy for newly diagnosed advanced-stage germ cell tumors, but it does not cure every patient. Paclitaxel, ifosfamide, and cisplatin are anticancer drugs used together to treat patients whose tumors have returned following bleomycin/etoposide/cisplatin. Prior clinical studies have shown that using paclitaxel/ifosfamide/cisplatin as the initial treatment in patients with advanced germ cell cancers may be more effective than the standard therapy.

In this study, researchers want to compare these two treatment regimens in patients with previously untreated advanced germ cell tumors. Patients will be randomly assigned to receive paclitaxel/ifosfamide/cisplatin or bleomycin/etoposide/cisplatin as initial therapy. All of these drugs are approved for treating various types of cancer.

Eligibility

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

  • Patients must be newly diagnosed with an advanced germ cell tumor that is intermediate-risk or poor-risk.
  • Patients may not have received prior chemotherapy other than one or two cycles of carboplatin. For those who had radiation therapy, their disease must have continued to grow despite treatment.
  • This study is open to patients age 18 and older and to both men and women.

For more information and to inquire about eligibility for this study, please contact Dr. Darren Feldman at 646-422-4491.

Disease(s)
Germ Cell Tumors