Status:
COMPLETED
S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 i...
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 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed chondrosarcoma
- Histologic grade G2 or G3
- Recurrent and unresectable OR metastatic disease
- Measurable disease by x-ray, scan, ultrasound, or physical examination
- No known CNS metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- SGOT or SGPT \< 2.5 times ULN (5 times ULN if liver metastases are present)
- Renal
- Creatinine clearance \> 45 mL/min
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to swallow oral medication
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 28 days since prior biologic therapy for this malignancy
- Chemotherapy
- More than 28 days since prior chemotherapy for this malignancy
- Endocrine therapy
- Not specified
- Radiotherapy
- At least 60 days since prior radiotherapy to the target lesion\*
- No concurrent radiotherapy NOTE: \*Target lesion must have demonstrated disease progression after completion of therapy
- Surgery
- At least 21 days since prior surgery and recovered
- Other
- More than 28 days since prior investigational drugs for this malignancy
- At least 60 days since prior embolization or radiofrequency ablation to the target lesion\*
- No more than 2 prior treatment regimens for this malignancy
- No concurrent antiretroviral therapy for HIV-positive patients NOTE: \*Target lesion must have demonstrated disease progression after completion of therapy
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00107419
Start Date
September 1 2005
End Date
August 1 2009
Last Update
January 18 2012
Active Locations (58)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
2
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
3
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
4
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435