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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00072267
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
* Progressive, persistent, or recurrent disease
* Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy
* Tumor lesions accessible for biopsy
* Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator
* No more than 2 prior chemotherapy regimens
* At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin)
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* More than 12 weeks
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN
Renal
* Creatinine no greater than ULN OR
* Creatinine clearance at least 50 mL/min
Cardiovascular
* No history of coronary artery disease
* No symptomatic cardiac dysfunction
* No cardiac pathology by electrocardiogram\* NOTE: \*Patients with symptomatic coronary artery disease must undergo an electrocardiogram
Pulmonary
* No symptomatic pulmonary dysfunction
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 8 weeks after study participation
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents
* No insulin-dependent diabetes mellitus
* Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior biologic therapy and recovered
Chemotherapy
* See Disease Characterisitcs
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No prior topotecan
* No other prior topoisomerase I inhibitors
Endocrine therapy
* More than 4 weeks since prior hormonal therapy and recovered
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy and recovered
* No prior radiotherapy to more than 40% of bone marrow
* No prior mediastinal irradiation
Surgery
* More than 4 weeks since prior surgery and recovered
Other
* No other concurrent anticancer therapy
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00072267
Study Brief:
Protocol Section:
NCT00072267