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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00047632
Eligibility Criteria:
Inclusion criteria:
* Histologically confirmed epithelial ovarian or primary peritoneal carcinoma, FIGO Stage III or IV disease. Patients with either optimal (\<= 1 cm residual disease) or suboptimal residual disease following initial surgery are eligible. Unstained slides of the primary tumor, a primary tumor block, or cytological preparation must be available for review.
* Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
* \<= 12 weeks after initial surgery with adequate recovery from surgery.
* Candidate for first-line chemotherapy
* Adequate bone marrow function (ANC \>= 1,500/mL; platelets \>= 100,000/mL; hemoglobin \>= 10 gm/dL)
* Adequate hepatic function (AST, ALT, and alkaline phosphatase \<= 2.5 x upper limit of normal; bilirubin \<= 1.5 x upper limit of normal).
* Adequate renal function (creatinine \<= 1.5 x upper limit of normal).
* Adequate neurologic function (sensory and motor neuropathy \<= NCI CTC Grade 1).
* Negative urine pregnancy test in women of child-bearing potential (within 14 days of the initiation of the first chemotherapy cycle).
* Zubrod / ECOG / GOG performance score 0-2.
* Able to give informed consent.
Exclusion criteria:
* Epithelial ovarian tumors of low malignant potential (borderline carcinomas). If diagnosis is based on cytology alone \[(e.g., fine needle aspiration (FNA)\], slides must be available, and confounding carcinomas such as non-ovarian mucinous, colorectal, Fallopian tube, and other adenocarcinomas of non-ovarian origin must be ruled out.
* Prior therapy for ovarian or primary peritoneal carcinoma other than primary surgical debulking.
* Patients for whom therapy for ovarian or primary peritoneal carcinoma in addition to protocol therapy is planned.
* Prior biological response modifier (BRM) for any reason within the previous 5 years.
* Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix. Patients who have had a malignancy \> 5 years previously may be eligible for this trial if they have not received any anti-neoplastic treatment within the previous 5 years an dif they have been without any evidence of disease for the previous 5 years.
* Uncontrolled infection.
* Pregnant or nursing women are excluded. Women of child-bearing potential must agree to use a chemical or barrier contraceptive during the dosing portion of the study.
* Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00047632
Study Brief:
Protocol Section:
NCT00047632