NCT00107419

S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma

Phase II Trial of Pemetrexed for Advanced Chondrosarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	pemetrexed disodium	pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-05-01
• Completion: 2009-08-01
• First posted: 2005-04-06
• Last updated: 2012-01-18

Locations

58 sites across 1 country: United States