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:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT00004066
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed leiomyosarcoma (LMS) or other soft tissue sarcoma
* No gastrointestinal stromal tumors, chondrosarcoma, Kaposi's sarcoma, Ewing's sarcoma, osteosarcoma, or mesotheliomas
* Recurrent or progressive disease defined as an increase in the size of any existing tumor (or the development of new tumors) that is not amenable to definitive surgical therapy
* No prior chemotherapy OR
* Failed no more than 2 prior chemotherapy regimens for LMS of the uterus or other soft tissue sarcoma
* Bidimensionally measurable disease by physical examination or medical imaging techniques
* Ascites and pleural effusions are not considered measurable disease
* No uncontrolled CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
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 mg/dL
Renal:
* Creatinine no greater than 2.0 mg/dL
Other:
* No active or uncontrolled infection
* No other prior malignancy except non-metastatic squamous cell or basal cell skin cancer or non-invasive carcinoma in situ of the cervix
* No history of grade 3 or 4 peripheral neuropathy
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy
* No prior gemcitabine or docetaxel
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 6 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004066
Study Brief:
Protocol Section:
NCT00004066