NCT00107419CompletedPhase 2
Phase II Trial of Pemetrexed for Advanced Chondrosarcomas
SWOG Cancer Research Network57 sites in 1 country75 target enrollmentStarted: September 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 75
- Locations
- 57
- Primary Endpoint
- Response rate as measured by RECIST criteria
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
pemetrexed
Experimental
pemetrexed
Intervention: pemetrexed disodium (Drug)
Outcomes
Primary Outcomes
Response rate as measured by RECIST criteria
Time Frame: every 9 weeks during treatment
x-rays or scans
Secondary Outcomes
- Toxicity as measured by CTC v 3.0(every 3 weeks during treatment)
- Response rate compared with methylthioadenosine phosphorylase (MTAP) deletions as measured by fluorescence in-situ hybridization (FISH) retrospectively(end of study)
Investigators
Study Sites (57)
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