RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent endometrial cancer.

OBJECTIVES:

• Determine the antitumor cytostatic activity of thalidomide, in terms of 6-month progression-free survival, in patients with recurrent or persistent endometrial carcinoma.
• Determine the nature and degree of toxicity of this drug in these patients.
• Determine the partial and complete response rates in patients treated with this drug.
• Determine the duration of progression-free and overall survival in patients treated with this drug.
• Determine the effect of this drug on initial performance status and histological grade in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 26 months.

DISEASE CHARACTERISTICS:

• 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 OR
  • 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

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• GOG 0-2 if patient received 1 prior regimen
• GOG 0-1 if patient received 2 prior regimens

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• 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

Renal:

• Creatinine no greater than 1.5 times ULN OR
• Creatinine clearance greater than 60 mL/min

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic or immunologic agents directed at malignancy
• No prior thalidomide

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy directed at malignancy and recovered

Endocrine therapy:

• At least 1 week since prior hormonal therapy directed at malignancy
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• 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

Surgery:

• Recovered from prior surgery

Other:

• 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)