A Phase II Evaluation Of Gleevec™ (NCI-Supplied Agent: STI571 [Imatinib Mesylate], IND #61135, NSC #716051) In The Treatment Of Recurrent Or Persistent Carcinosarcoma Of The Uterus
Inclusion Criteria:
- 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
- Performance status - GOG 0-2 (for patients who have received 1 prior regimen)
- Performance status - GOG 0-1 (for patients who have received 2 prior regimens)
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- 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
- Creatinine no greater than 1.5 times ULN
- 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
- No pulmonary embolism within the past 6 weeks
- 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
- 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
- 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
- At least 1 week since prior hormonal therapy directed at the malignant tumor
- Concurrent hormone replacement therapy allowed
- No concurrent therapeutic corticosteroids
- See Disease Characteristics
- Recovered from prior radiotherapy
- Recovered from prior surgery
- 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
