Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

Inclusion Criteria

• Histologically confirmed uterine sarcoma
• Carcinosarcoma (malignant mixed müllerian tumor)
• Homologous or heterologous type
• Recurrent or persistent with documented disease progression after prior local therapy
• At least 1 unidimensionally measurable target lesion
• At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI
• At least 10 mm by spiral CT scan
• Tumors within a previously irradiated field are considered non-target lesions
• Must have received 1 prior initial chemotherapy regimen (including high-dose ,consolidation, or extended therapy after surgical or nonsurgical assessment) for carcinosarcoma
• No documented brain metastases since diagnosis of cancer
• Patients with stable CNS deficits are allowed provided that there is no evidence of brain metastases on CT scan or MRI
• Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), including any active phase III GOG protocol for the same patient population
• Performance status - GOG 0-2 if received 1 prior therapy regimen
• Performance status - GOG 0-1 if received 2 prior therapy 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
• Creatinine clearance greater than 60 mL/min
• Not pregnant
• Negative pregnancy test
• Fertile patients must use at least 1 highly active method of contraception and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation
• No seizure disorders since diagnosis of cancer
• Patients with a history of seizure disorders are allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen
• No active infection requiring antibiotics
• No greater than grade 1 sensory or motor neuropathy
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• At least 3 weeks since prior immunologic agents for uterine sarcoma
• No prior thalidomide
• See Disease Characteristics
• At least 3 weeks since prior chemotherapy for uterine sarcoma and recovered
• No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine sarcoma
• No prior non-cytotoxic chemotherapy for recurrent or persistent uterine sarcoma
• No concurrent bisphosphonates (e.g., zoledronate)
• At least 1 week since prior hormonal therapy for uterine sarcoma
• Concurrent hormone replacement therapy allowed
• See Disease Characteristics
• At least 3 weeks since prior radiotherapy for uterine sarcoma and recovered
• No prior radiotherapy to more than 25% of marrow-bearing areas
• See Disease Characteristics
• Recovered from prior surgery
• At least 3 weeks since any other prior therapy for uterine sarcoma
• No prior anticancer therapy that would preclude study