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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00466960
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically proven epithelial ovarian, fallopian tube or primary peritoneal malignancies, excluding tumors of low malignant potential (borderline)
* 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 not otherwise specified
* Patients must have either primary platinum refractory or resistant carcinoma or secondary platinum resistant disease:
1. Primary platinum refractory disease is defined as progression of disease on initial platinum-based chemotherapy or persistent disease at the conclusion of the initial platinum-based chemotherapy course associated with the primary debulking surgery.
2. Primary platinum resistant disease is defined as recurrence of carcinoma within 6 months (+ 14 days) of completion of initial platinum-based chemotherapy associated with the primary debulking surgery. (The 14 day window is to allow study entry for those patients where evidence clearly suggests that had an assessment been made early the patient would have met the 6 month time line. This will be determined by the study principal investigator \[P.I.\])
3. Secondary platinum resistant disease is defined as meeting any one of the listed criteria during or following a subsequent platinum containing regimen.
* Patients must have an elevated serum cancer antigen (CA)125 on two occasions greater than 7 days apart
* Absolute neutrophil count \>= 1500/uL
* Platelets \>= 100,000/uL
* Creatinine =\< 2.0 mg/dL
* Total bilirubin =\< 1.5 mg/dL (unless history of Gilbert's disease)
* Serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 x upper limit of normal (ULN) or \< 5 x ULN with documented report of hepatic metastases
* Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy; at least three weeks must have elapsed since prior chemotherapy or radiation therapy
Exclusion Criteria:
* Patient has an allergic history to paclitaxel or GM-CSF, not manageable by pre-medication and/or slow drug infusion
* Patient has poorly controlled arrhythmias or unstable coronary artery disease or has had a myocardial infarction within the last six months
* Patient with active pulmonary edema or pleural effusion
* Active infection requiring IV antibiotics
* Patient currently requires lithium, (due to drug interaction with GM-CSF \[Leukine\])
* Patient currently presents with a neurotoxicity \> Grade 1
* Women of childbearing potential
* Patients with a history of other invasive malignancies, within the previous 5 years are excluded, with the exception of non-melanoma skin cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00466960
Study Brief:
Protocol Section:
NCT00466960