Thalidomide in Treating Patients With Gynecologic Sarcomas

Study Overview
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Brief Summary
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RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas 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 gynecologic sarcomas.

Detailed Description
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OBJECTIVES: Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin. Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population. Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients. OUTLINE: Patients receive oral thalidomide daily. Treatment continues 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: A total of 60 patients will be accrued for this study within 18 months.

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

Conditions
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Endometrial Cancer, Sarcoma

Intervention / Treatment
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* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma