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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT00005051
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery
* Stage IC, II, III, or IV
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* SGOT no greater than 3 times upper limit of normal
* Bilirubin no greater than 2.0 mg/dL
* No clinically significant hepatic disorder
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
* No clinically significant renal disorder
Cardiovascular:
* No clinically significant cardiovascular condition
Other:
* Normal GI function allowing reliable administration of oral medication
* No active infection requiring systemic medical therapy within past week
* No other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder)
* No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No dementia or altered mental status that would preclude consent
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for ovarian epithelial carcinoma
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for ovarian epithelial carcinoma
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00005051
Study Brief:
Protocol Section:
NCT00005051