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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00183794
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven diagnosis of epithelial ovarian ca
* Must have platinum-resistant disease. (Defined as progression during the most recent platinum-based chemotx or relapse \< 6 months after the most recent platinum-based chemotx regimen.)
* Measurable or evaluable disease. (Patients whose dz is manifested only as an elevated CA-125 \[greater than or equal to 100\] are eligible. If an elevated CA-125 is the only manifestation of dz, it must be confirmed on 2 separate times, at least 2 weeks apart. Patients with positive cytology only are not eligible.)
* Greater than or equal to 18 years of age
* GOG performance status less than or equal to 2
* AGC/ANC greater than or equal to 1.5; platelets greater than or equal to 100,000; hemoglobin (Hgb) greater than or equal to 8.0.
* Creatinine less than or equal to 2.0
* Total bilirubin less than or equal to upper limit of normal (uln)
* SGOT and/or SGPT less than or equal to 2.5 x uln if alkaline phosphatase less than or equal to uln, or alkaline phosphatase less than or equal to 4 x uln if transaminases are less than or equal to uln. (If both SGOT/SGPT \>1.5 x uln and alkaline phosphatase \> 2.5 x uln, patient is not eligible.)
* Fully recovered from acute toxicities secondary to prior treatment (tx)
* Signed informed consent
Exclusion Criteria:
* Prior treatment with gemcitabine or docetaxel
* Underlying medical, psychiatric, or social conditions that would preclude patient from receiving treatment
* Peripheral neuropathy greater than or equal to Grade 2
* No prior tx with cisplatin or carboplatin
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00183794
Study Brief:
Protocol Section:
NCT00183794