Protocol
09-034
Full Title
A Non-Randomized Phase II Study of Alvocidib (Flavopiridol) Plus Oxaliplatin With or Without 5-FU Leucovorin for Relapsed or Refractory Germ Cell Tumors (NCI #8258)
Purpose
The purpose of this study is to evaluate the safety and effectiveness of the combination of the drugs flavopiridol and oxaliplatin, with or without fluorouracil (5-FU) and leucovorin, in patients with advanced germ cell tumors that have persisted or returned despite standard therapy.
Oxaliplatin, leucovorin, and 5-FU are commonly used to treat colorectal cancer, but their use in this study is considered investigational. Flavopiridol is an investigational drug that may work by inhibiting key enzymes that cancer cells need to grow and multiply. It has been shown in other studies to enhance the anticancer effects of other chemotherapy drugs.
In this study, patients will receive flavopiridol and oxaliplatin with or without 5-FU and leucovorin. Treatment is administered every 2 weeks and will only be given at Memorial Sloan-Kettering Cancer Center.
Investigator
Feldman, Darren, MD
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 an advanced germ cell tumor that has persisted or returned despite standard therapy.
- Patients may not be candidates for high-dose chemotherapy or must have already had high-dose chemotherapy.
- There is no limit to the number of prior therapies a patient may have received. However, no prior treatment with oxaliplatin or flavopiridol is allowed.
- At least 2 weeks must have passed since completion of prior therapy (4 weeks since any major surgery) and entry into the study, and patients must have recovered from any side effects.
- Patients must be age 18 or older.
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
Seminoma
Testicular Cancer
