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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT00227669
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed uterine or soft tissue leiomyosarcoma, meeting ≥ 1 of the following criteria:
* Metastatic disease
* Relapsed and unresectable disease
* Prior treatment with a first-line anthracycline-based chemotherapy regimen required
* Relapsed disease \> 1 year after adjuvant chemotherapy is considered untreated disease
* If relapsed disease occurs \< 1 year after adjuvant therapy, then adjuvant therapy is considered a first-line treatment
* At least 1 measurable lesion, defined as the following:
* At least 1 target lesion must be located in a non-irradiated area
* Obvious disease progression within the past 6 weeks
* No other uterine sarcomas, including any of the following:
* Carcinosarcoma
* Endometrial stroma sarcoma
* Other soft tissue sarcoma
* No symptomatic or known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* No specific hepatic contraindication to study treatment
* Hepatitis B core and hepatitis B surface antigen negative
Renal
* Creatinine \< 1.5 times ULN
* No specific renal contraindication to study treatment
Cardiovascular
* No specific cardiac contraindication to study treatment
Immunologic
* HIV negative
* No specific allergic contraindication to study treatment
* No active infection
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other serious underlying pathology that would preclude study treatment
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No neurotoxicity \> grade 2
* No psychological, sociological, or geographical condition that would preclude study compliance or follow-up schedule
* No prior or concurrent psychiatric illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior immunotherapy
* No prior allogeneic graft or autologous graft
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy
* No prior gemcitabine and/or taxane (i.e., docetaxel or paclitaxel)
Endocrine therapy
* More than 4 weeks since prior hormonal therapy
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy to the only evaluable lesion
Surgery
* Not specified
Other
* No concurrent participation in another clinical trial using an experimental agent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00227669
Study Brief:
Protocol Section:
NCT00227669