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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT00334893
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
* Recurrent disease after ≥ 1 prior therapy, meeting 1 of the following criteria:
* Platinum-resistant disease (progression-free interval \< 6 months)
* Platinum-sensitive disease (progression-free interval ≥ 6 months)
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mmby conventional techniques OR ≥ 10 mm by spiral CT scan
* No known brain metastasis
* Life expectancy \> 2 months
* ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* WBC ≥ 3,000/mm\^3
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatine normal OR creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
* Stage IA or IB endometrial cancer within the past 5 years allowed provided patient is considered disease free
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to E7389
* No HIV positivity
* No ongoing or active infection
* No cardiac arrhythmia
* No unstable angina pectoris
* No symptomatic congestive heart failure
* No psychiatric illness or social situations that would preclude study compliance
* No other uncontrolled intercurrent illness
* See Disease Characteristics
* Recovered from effects of recent surgery, radiotherapy, or chemotherapy
* No more than 2 prior cytotoxic therapies with no more than 1 non platinum, non taxane regimen
* No prior E7389
* More than 14 days since prior hormonal therapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
* More than 4 weeks since prior radiotherapy
* No concurrent antitumor hormonal therapy
* No other concurrent investigational agents
* No other concurrent anticancer agents or therapies
* No granulocyte colony-stimulating factors during the first course of study therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00334893
Study Brief:
Protocol Section:
NCT00334893