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