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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT00052468
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of one of the following:
* Ovarian epithelial cancer
* FIGO stage IA/B G3, IC-IV
* Fallopian tube cancer
* Extra-ovarian papillary serous tumor
* The following are ineligible:
* Low malignant-potential ovarian tumors (borderline tumors)
* Non-epithelial ovarian tumors
* Mixed Mullerian tumors
* Must have had definitive surgery within the past 6 weeks
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 6 months
Hematopoietic
* WBC at least 3,000/mm\^3 OR
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10 mg/dL
Hepatic
* Bilirubin no greater than 2 times upper limit of normal
Renal
* Glomerular filtration rate at least 50 mL/min
Cardiovascular
* No congestive heart failure
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart disease
* No prior atrial or ventricular arrhythmias
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior seizures or central nervous system disorder
* No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K)
* No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel
* No preexisting motor or sensory neuropathy greater than grade 1
* No other malignancy within the past 5 years except:
* Malignancies cured by surgery alone
* Carcinoma in situ of the cervix
* Adequately treated basal cell skin cancer
* No complete bowel obstruction
* No other concurrent severe medical condition that would preclude study participation
* No dementia or significantly altered mental status that would preclude study participation
* No concurrent severe active infection
* Geographically accessible for treatment and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy except:
* Hormone replacement therapy
* Antiemetic steroids
Radiotherapy
* No prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Other
* No other concurrent antineoplastic agents
* No other concurrent investigational drugs
* No other concurrent clinical trial enrollment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00052468
Study Brief:
Protocol Section:
NCT00052468