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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pemetrexed

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