NCT00107419
S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma
PHASE2
COMPLETED
NCT00107419
INTERVENTIONAL
Phase II Trial of Pemetrexed for Advanced Chondrosarcomas
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.
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
Sarcoma
- TREATMENT
-
- Type: DRUG
- Name: pemetrexed disodium
- Description: pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression
- Arm Group Labels: pemetrexed
- SWOG Cancer Research Network