Sarcoma
Conditions
Keywords
chondrosarcoma
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. 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.
Interventions
DRUGpemetrexed disodium
pemetrexed, 500 mg/m2, IV, every 21 days until two cycles after complete response or until progression
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate as measured by RECIST criteria | every 9 weeks during treatment | x-rays or scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity as measured by CTC v 3.0 | 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 | end of study | — |
Countries
United States
Outcome results
None listed