S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma
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|ClinicalTrials.gov Identifier: NCT00107419|
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : January 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: pemetrexed disodium||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pemetrexed for Advanced Chondrosarcomas|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||August 2009|
Drug: pemetrexed disodium
pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression
- Response rate as measured by RECIST criteria [ Time Frame: every 9 weeks during treatment ]x-rays or scans
- Toxicity as measured by CTC v 3.0 [ Time Frame: every 3 weeks during treatment ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107419
|Study Chair:||Warren A. Chow, MD||City of Hope Comprehensive Cancer Center|
|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|