thalidomide in treating patients with gynecologic sarcomas

Conditions: Endometrial Cancer; Sarcoma

Summary: 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.

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.

Eligibility 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

Keywords: 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