Phase
Condition
Fallopian Tube Cancer
Peritoneal Cancer
Carcinoma
Treatment
FACT-O Quality of Life Questionnaire
Second look laparoscopy reassessment surgery (SLLRS)
HIPEC with Carboplatin
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have histologically I-III epithelial carcinoma of the ovary, fallopiantube or peritoneum or Stage IVA disease in which is there complete resolution ofdisease (pleural effusion) with chemotherapy
Patients must have undergone cytoreductive surgery and 3-8 cycles of platinum-basedsystemic chemotherapy prior to the second look surgery. Systemic platinum basedchemotherapy must be completed less than 18 weeks prior to second look surgery.
Cytoreductive surgery must result in an R-0, R-1 resection prior to systemicchemotherapy
The intraoperative peritoneal adhesion index should be < 10.
Patients must be without clinical evidence of disease including a negative exam,imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemicchemotherapy.
Age ≥ 18 years.
ECOG performance status ≤ 2.
Patients must have adequate organ and marrow function as defined below (within 30days of registration): absolute neutrophil count >1,500/mcL; platelets >100,000/mcL;total bilirubin ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mg/dL; AST(SGOT)/ALT(SGPT) ≤ 3X; institutional upper limit of normal; alkaline phosphatase 3X institutional upperlimit of normal
Adequate contraception and negative pregnancy test if pregnancy possible.
Ability to understand and the willingness to sign an IRB-approved informed consentdocument.
Exclusion
Exclusion Criteria:
Patients greater than 18 weeks from their last course of systemic platinum basedchemotherapy
Patients who have received additional chemotherapy for the ovarian cancer afterprimary therapy as outlined above.
Patients may not have received prior abdominal or pelvic radiation.
Extensive intra-abdominal adhesive disease noted at the time of initialcytoreductive surgery with PAI of >10 as defined above
Intra-abdominal infection associated with initial cytoreductive surgery requiringextended hospitalization or related to systemic chemotherapy requiringhospitalization for therapy
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to carboplatin.
Uncontrolled intercurrent illness including, but not limited to ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.
Pregnancy
Men are excluded from participation due to the site-specific nature of the disease being studied.
Study Design
Study Description
Connect with a study center
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
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