• Progression-free survival at 6 months [ Designated as safety issue: No ]
  
• Frequency and severity of adverse effects as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  

• Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
  
• Clinical response (partial and complete) as assessed by RECIST [ Designated as safety issue: No ]
  
• Prognostic factors (initial performance status and histological grade) [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the activity of imatinib mesylate, in terms of 6-month progression-free survival, in patients with recurrent or persistent uterine carcinosarcoma.
• Determine the frequency and severity of adverse effects of this drug in these patients.

Secondary

• Determine the distribution of overall and progression-free survival in patients treated with this drug.
• Determine the objective response rate (partial and complete response) in patients treated with this drug.
• Determine the effects of this drug on prognostic factors (initial performance status and histological grade) in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 15-30 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed uterine carcinosarcoma

  • Malignant mixed Mullerian tumor, homologous or heterologous type
  • Persistent or recurrent disease
• Progressive disease after prior local therapy
• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• Presence of at least 1 target lesion (to be used to assess response)

  • Tumors within a previously irradiated field are considered non-target lesions

• Received 1 prior chemotherapy regimen for carcinosarcoma

  • Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • One additional prior cytotoxic regimen for recurrent or persistent disease allowed
• Ineligible for a higher priority GOG protocol
• No clinically apparent CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• GOG 0-2 (for patients who have received 1 prior regimen) OR
• GOG 0-1 (for patients who have received 2 prior regimens)

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No deep venous or arterial thrombosis within the past 6 weeks
• No myocardial infarction within the past 6 months
• No congestive heart failure requiring therapy

Pulmonary

• No pulmonary embolism within the past 6 weeks

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after study participation
• No history of seizures
• No sensory or motor neuropathy greater than grade 1
• No signs or symptoms of bowel dysfunction or obstruction
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No active or uncontrolled infection requiring antibiotics
• No other concurrent severe disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 weeks since prior immunologic agents directed at the malignant tumor
• No concurrent biologic agents directed at the malignant tumor
• No concurrent prophylactic growth factors
• No concurrent prophylactic thrombopoietic agents

Chemotherapy

• See Disease Characteristics
• Recovered from prior chemotherapy
• No prior non-cytotoxic chemotherapy for recurrent or persistent disease
• No concurrent chemotherapy directed at the malignant tumor

Endocrine therapy

• At least 1 week since prior hormonal therapy directed at the malignant tumor
• Concurrent hormone replacement therapy allowed
• No concurrent therapeutic corticosteroids

Radiotherapy

• See Disease Characteristics
• Recovered from prior radiotherapy

Surgery

• Recovered from prior surgery

Other

• At least 3 weeks since other prior therapy directed at the malignant tumor
• No prior imatinib mesylate
• No prior cancer treatment that would contraindicate study therapy
• No concurrent therapeutic anticoagulation with warfarin
• No concurrent amifostine or other protective agents
• No concurrent phenytoin, phenobarbital, or carbamazepine
• No other concurrent therapy directed at the malignant tumor
• No other concurrent investigational drugs