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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT00217568
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
* Stage III or IV disease
* No borderline tumors
* Measurable or evaluable disease
* Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
* Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)
* In first relapse
* Platinum-sensitive disease, defined as initial relapse \> 6 months after completion of a platinum-based regimen
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
Hepatic
* Bilirubin normal
* Meets 1 of the following criteria:
* SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
* SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal
Renal
* Creatinine ≤ 2.0 mg/dL
* Creatinine clearance \> 50 mL/min
Cardiovascular
* LVEF ≥ 50%
* No poorly controlled arrhythmia
* No unstable coronary artery disease or myocardial infarction within the past year
Other
* HIV negative
* No pre-existing peripheral neuropathy \> grade 2
* No history of allergy to study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* At least 3 weeks since prior radiotherapy and recovered
Surgery
* Recovered from recent prior surgery
Other
* No concurrent myelosuppressive therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00217568
Study Brief:
Protocol Section:
NCT00217568