Clinical trial NCT00025467 (phase 2, status: completed)
Conditions: endometrial adenoacanthoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma, endometrial clear cell carcinoma, endometrial papillary serous carcinoma, recurrent endometrial carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: thalidomide
SMILES: CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
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)