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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT00060359
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma
* Stage III or IV
* Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
* The following histologic epithelial cell types are eligible:
* Serous adenocarcinoma
* Mucinous adenocarcinoma
* Clear cell adenocarcinoma
* Transitional cell carcinoma
* Adenocarcinoma not otherwise specified
* Endometrioid adenocarcinoma
* Undifferentiated carcinoma
* Mixed epithelial carcinoma
* Malignant Brenner tumor
* No epithelial tumors of low malignant potential (borderline tumors)
* Surgery performed within the past 12 weeks
* Performance status - GOG 0-2
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No active bleeding
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastasis)
* Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastasis)
* No acute hepatitis
* PT and PTT normal
* Creatinine no greater than 1.5 times ULN
* Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for the past 6 months
* No myocardial infarction within the past 6 months
* No unstable angina
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No neuropathy (sensory or motor) grade 2 or worse
* No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or localized breast cancer
* No active infection requiring antibiotics
* No circumstances that would preclude study completion or follow-up
* More than 3 years since prior adjuvant chemotherapy for localized breast cancer (must be free of recurrent or metastatic disease)
* More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin (must be free of recurrent or metastatic disease)
* No prior radiotherapy to any portion of the abdominal cavity or pelvis
* No prior treatment, other than debulking surgery, for this cancer
* No prior treatment for another cancer that would contraindicate this protocol therapy
* No concurrent amifostine or other protective reagents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00060359
Study Brief:
Protocol Section:
NCT00060359