S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent and unresectable or metastatic chondrosarcoma.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Pemetrexed for Advanced Chondrosarcomas|
- Response rate as measured by RECIST criteria [ Time Frame: every 9 weeks during treatment ] [ Designated as safety issue: No ]x-rays or scans
- Toxicity as measured by CTC v 3.0 [ Time Frame: every 3 weeks during treatment ] [ Designated as safety issue: Yes ]side-effect evaluation
- Response rate compared with methylthioadenosine phosphorylase (MTAP) deletions as measured by fluorescence in-situ hybridization (FISH) retrospectively [ Time Frame: end of study ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||August 2009|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Drug: pemetrexed disodium
pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression
- Determine the response rate (confirmed and unconfirmed complete response and partial response) in patients with recurrent and unresectable or metastatic chondrosarcoma treated with pemetrexed disodium.
- Determine the toxicity of this drug in these patients.
- Correlate, preliminarily, response rates with deletions of methylthioadenosine phosphorylase (MTAP), as analyzed by fluorescence in-situ hybridization (FISH), in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no).
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity. Beginning 7 days before the first dose of pemetrexed disodium and continuing until 21 days after the completion of pemetrexed disodium, patients receive cyanocobalamin (vitamin B_12) intramuscularly once every 63 days and oral folic acid once daily.
NOTE: *The duration of course 1 is 28 days; the duration of all subsequent courses is 21 days.
Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients achieving a confirmed partial response (PR) that is resectable, proceed to surgical resection and then receive 2 additional courses of therapy after recovering from surgery. Patients achieving a confirmed PR that is not resectable continue treatment in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 40-75 patients (20-40 in the previously treated stratum and 20-35 in the previously untreated stratum) will be accrued for this study within 20-37.5 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107419
Show 58 Study Locations
|Study Chair:||Warren A. Chow, MD||Beckman Research Institute|
|Study Chair:||Ernest C. Borden, MD||The Cleveland Clinic|
|Study Chair:||Vivien H.C. Bramwell, MB, BS, PhD, FRCP||Tom Baker Cancer Centre - Calgary|
|Study Chair:||George D. Demetri, MD||Dana-Farber Cancer Institute|
|Study Chair:||Margaret von Mehren, MD||Fox Chase Cancer Center|