Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Endometrial Adenoacanthoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed endometrial carcinoma Recurrent or persistent (refractory to curative therapy or established treatment) No sarcomas At least 1 unidimensionally measurable 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 At least 1 target lesion outside the area of prior radiotherapy Received 1 prior chemotherapy regimen for endometrial carcinoma Initial treatment may include high-dose therapy, consolidation, or extended therapy No more than 1 additional cytotoxic regimen for recurrent or persistent disease No non-cytotoxic chemotherapy for recurrent or persistent disease Ineligible for higher priority GOG protocols (any active GOG phase III protocol for the same patient population) No documented brain metastases since diagnosis of cancer Patients with stable CNS deficits allowed provided there are no brain metastases, as confirmed by CT scan or MRI Performance status - GOG 0-2 if patient received 1 prior regimen Performance status - GOG 0-1 if patient 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 Creatinine clearance greater than 60 mL/min Not pregnant Negative pregnancy test Fertile patients must use 2 methods of effective contraception for 4 weeks before, during, and for 4 weeks after study participation No active infection requiring antibiotics No sensory or motor neuropathy greater than grade 1 No other invasive malignancy within the past 5 years except non-melanoma skin cancer No documented seizure disorders since diagnosis of cancer Patients with a history of seizure disorders allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen At least 3 weeks since prior biologic or immunologic agents directed at malignancy No prior thalidomide See Disease Characteristics At least 3 weeks since prior chemotherapy directed at malignancy and recovered At least 1 week since prior hormonal therapy directed at malignancy Concurrent hormone replacement therapy allowed See Disease Characteristics At least 3 weeks since prior radiotherapy directed at malignancy and recovered No prior radiotherapy to more than 25% of marrow-bearing areas Recovered from prior surgery At least 3 weeks since any other prior therapy directed at malignancy No prior cancer therapy that would preclude study participation No concurrent bisphosphonates (e.g., zoledronate)
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.