Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-25 @ 3:17 AM
NCT ID:
NCT00006005
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
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00006005
Study Brief:
Protocol Section:
NCT00006005