Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus
Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma
About this trial
This is an interventional treatment trial for Recurrent Uterine Corpus Sarcoma
Eligibility Criteria
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
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (thalidomide)
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.