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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00003560
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed previously untreated ovarian cancer, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma
* Suboptimally debulked stage III or suboptimally or optimally debulked stage IV
* Measurable or evaluable disease
* CNS lesions, lytic bone lesions, and radiated lesions (unless there is documented progression after radiotherapy) are not considered measurable
* CA 125 levels above 49 units/mL in the absence of cirrhosis or nonmalignant gross ascites are considered evaluable
* Ineligible for other high-priority national or institutional study
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-1
Life expectancy:
* More than 2 months
Hematopoietic:
* WBC greater than 3,000/mm3
* Platelet count greater than 100,000/mm3
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT and/or SGPT less than 2.5 times ULN OR
* SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR
* Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN
* No SGOT and/or SGPT greater than 1.5 times ULN with alkaline phosphatase greater than 2.5 times ULN
* Alkaline phosphatase less than 350 U/L
Renal:
* BUN less than 1.5 times normal
* Creatinine less than 1.5 times ULN
Other:
* No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer
* No other serious medical or psychiatric illness
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormone therapy
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00003560
Study Brief:
Protocol Section:
NCT00003560