Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed sarcoma or carcinosarcoma (mixed mesodermal
tumors) of gynecologic origin not amenable to resection or radiotherapy

- Measurable disease

- Lesions accurately measured in at least 1 dimension of at least 20 mm in longest
diameter with conventional techniques or at least 10 mm with helical CT scan

- Histologically or cytologically confirmed neoplastic nature if solitary lesion

- No nonmeasurable disease, defined as:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Unconfirmed abdominal masses not followed by imaging techniques

- Cystic lesions

- Documented recurrence or persistence following appropriate surgery, radiotherapy,
and/or chemotherapy

- Postmenopausal or status post hysterectomy

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count at least 1,000/mm^3

- Platelet count at least 50,000/mm^3

Hepatic:

- Bilirubin normal

- Transaminases less than 2.5 times upper limit of normal

Renal:

- Creatinine less than 1.5 mg/dL

Other:

- No grade 2 or greater peripheral neuropathy

- No medical or social factors that would preclude study, including inability to take
oral medication

- No other serious illness requiring immediate therapy

- Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- At least 30 days since any prior noncytotoxic experimental antiemetic or antifungal
investigational drug