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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT00003732
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer
* Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients)
* No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Hemoglobin at least 9.0 g/dL
* WBC at least 3,500/mm3
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present
* Alkaline phosphatase no greater than 2 times ULN\*
* SGOT no greater than 2 times ULN\* NOTE: \*No greater than 5 times ULN if liver metastases present
Renal:
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment
* No myocardial infarction within the past 3 months
Other:
* No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No uncontrolled infection
* No complete bowel obstruction or other condition that would affect GI absorption or motility
* No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated
* No other concurrent medical conditions that would preclude study
* No mental disease
* No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K)
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
Chemotherapy:
* No prior camptothecin analogue
* No prior chemotherapy for ovarian cancer
* No other concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
* No concurrent hormonal therapy other than estrogen replacement
Radiotherapy:
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
Other:
* At least 30 days or 5 half-lives since any prior investigational therapy
* No other concurrent investigational therapy
* No concurrent metoclopramide or cisapride
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00003732
Study Brief:
Protocol Section:
NCT00003732