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 @ 12:14 PM
Ignite Modification Date:
2025-12-24 @ 12:14 PM
NCT ID:
NCT00019461
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer
* Measurable disease by physical exam, radiography, peritoneoscopy, or laparoscopy
* No more than 4 weeks since prior peritoneoscopy
* No brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 4 months
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL AND/OR
* Hematocrit at least 27%
Hepatic:
* SGOT/SGPT no greater than 3 times upper limit of normal
* Bilirubin normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* No history of symptomatic cardiac dysrhythmias requiring medication
* At least 6 months since prior myocardial infarction
* No unstable or newly diagnosed angina
Pulmonary:
* No obstructive lung disease requiring oxygen therapy
Other:
* Not pregnant or nursing
* HIV negative
* Must be able to take oral medication
* No concurrent medical condition (e.g., impending bowel obstruction)
* No grade 2 or greater residual peripheral neuropathy
* No active infection
* No other prior or concurrent invasive malignancy within the past 5 years
* No history of acute visual loss other than that associated with retinal detachment
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior cytokine therapy
* No concurrent cytokine therapy to maintain WBC count
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, or mitomycin)
* No other concurrent chemotherapy
Endocrine therapy:
* At least 4 weeks since prior hormonal therapy
* No concurrent corticosteroids at doses greater than physiological replacement doses
* No concurrent hormonal therapy
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
Other:
* No more than 3 prior treatment regimens
* At least 1 week since prior systemic antibiotics for infection
* No chronic antifungal treatment with antimycotic imidazoles
* No concurrent alternative therapies
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00019461
Study Brief:
Protocol Section:
NCT00019461