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A Phase I Trial of Doxorubicin and Flavopiridol in the Treatment of Metastatic Sarcoma
[Protocol 04-075]
- Full Title :
- PHASE I TRIAL OF DOXORUBICIN AND ALVOCIDIB (FLAVOPIRIDOL) (NCI SUPPLIED AGENT, NSC 649890) IN THE TREATMENT OF METASTATIC SARCOMA (NCI PROTOCOL #6204)
- Purpose :
Sometimes doctors can use chemotherapy to shrink sarcomas, but many people gain little or no benefit. In this study, investigators want to determine the highest dose of flavopiridol that can be given safely in combination with the standard chemotherapy drug doxorubicin (also known as Adriamycin®) to people with sarcoma that has returned or spread (metastasized), and to see if this drug combination has any activity against sarcoma.
Flavopiridol is an investigational drug that has been shown in laboratory studies to increase the effectiveness of several anticancer drugs, including doxorubicin. It may work by inhibiting key enzymes that cancer cells need to grow and multiply. Treatment with doxorubicin may work in some cancers, but not in all cases. The effects of doxorubicin are temporary. Adding flavopiridol to doxorubicin treatments may increase the anticancer effect seen with doxorubicin alone.
Some patients will be asked to give tissue samples from their tumors before and after chemotherapy in order to better understand the effects of these drugs on sarcoma.
- 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 soft-tissue sarcoma that has recurred or metastasized.
- Patients may have had up to two prior regimens of chemotherapy, and must have recovered from the side effects of treatment. At least 3 weeks must have passed since any prior chemotherapy, immunotherapy, or radiation therapy (6 weeks for BCNU or mitomycin C). Patients who have been previously treated with doxorubicin or other anthracyclines (such as epirubicin and liposomal doxorubicin) may not participate.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. David D'Adamo at 212-639-7573.
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