Protocol Number: 04-C-0001
-Gemcitabine and docetaxel are active antineoplastic agents with a broad spectrum of clinical activity. -In single agent phase I trials, gemcitabine and docetaxel have shown some activity in patients with Ewing's sarcoma and osteosarcoma. Chondrosarcomas are known to be refractory to standard chemotherapeutic regimens. -A variety of schedules and doses of gemcitabine in combination with docetaxel have been studied in clinical trials. -Two clinical trials have reported response rates of approximately 50% when the drugs are given sequentially with gemcitabine followed by docetaxel. In addition, in vitro data supports the synergy of sequential gemcitabine-docetaxel therapy.[3] Objectives -The primary objective of this study is to determine the objective response rate of sequential gemcitabine-docetaxel in patients with recurrent Ewing's sarcoma, recurrent osteosarcoma, and unresectable or locally recurrent chondrosarcomas. -Additionally, the pharmacokinetic of gemcitabine and docetaxel will be studied in this patient population and when available, tumor samples for cDNA microarray analysis of gene expression and development of cell lines and xenotransplantation models will be obtained. Eligibility -Subjects greater than or equal to 4 years of age with relapsed or refractory osteosarcoma, or Ewing's sarcoma or unresectable or locally recurrent chondrosarcoma are eligible. Design -The study will be conducted with the Sarcoma Alliance for Research through Collaboration (SARC). It is an open lable single stage phase 2 study conducted in 3 cohorts of patients (osteosarcoma, Ewing's sarcoma or chondrosarcoma). -Gemcitabine (675 mg/m(2)) is administered by intravenous infusion over 90minutes on day 1 and 8; docetaxel (75 mg/m(2)) by intravenous infusion over 1 hour is administered after gemcitabine on day 8. Growth factor support with filgrastim or pegfilgrastim begins on day 9. Each cycle is 21 days. -The study will be conducted using baysean formulation for each cohort. Threshold interesting response rate are 35% in each of the Ewing's and osteosarcoma subgroups, and 20% in the chondrosarcoma subgroup. Using baysean formulation, if the threshold interesting response rates are not maintained, the trial will be closed. A maximum of 40 patients will be enrolled to each cohort.
Search The Studies | Help | Questions |
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
|
||