Ovarian Cancer, Fallopian Tubes Cancer, Peritoneal Cancer
Conditions
Keywords
Secondary Cytoreductive Surgery, Carboplatin, Hyperthermic Intraperitoneal Chemotherapy (HIPEC), 12-275
Brief summary
The purpose of this study is to see if the investigators can improve the treatment of this type of cancer. They want to find out what effects, good and/or bad, giving heated chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has on the patient and this type of cancer. The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to get into and kill the cancer cells. The drug used for HIPEC will be carboplatin, a Food and Drug Administration (FDA) approved drug for use in ovarian, fallopian tube or primary peritoneal cancer.
Interventions
PROCEDURESecondary Cytoreductive Surgery
DRUGCarboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
DRUGplatinum-based systemic chemotherapy postoperatively
5 cycles
Sponsors
Mayo Clinic
Baptist Health South Florida
Hartford HealthCare
University of Pittsburgh
University of Chicago
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for Eligibility Prior to Surgery: * Age ≥ 21 years old. * Patients with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma that has recurred \>6 months since platinum-based chemotherapy (first recurrence) and who are scheduled for secondary surgical evaluation/cytoreduction. * Histologic epithelial cell types include serous, endometrioid, clear cell, or undifferentiated carcinomas, transitional cell carcinoma, mixed epithelial carcinoma, malignant Brenner's tumor, or adenocarcinoma N.O.S. * Karnofsky Performance Status (KPS) of ≥ 70%. * Disease-free interval ≤ 30 months. * No prior chemotherapy in the recurrent setting. Prior hormonal therapy is permitted. Concomitant anti-neoplastic anti-hormonal therapy (including tamoxifen, aromatase inhibitors etc.) is not allowed for patients participating in study treatment. Low-dose (physiologic) estrogen hormone-replacement therapy (HRT) may be given. * Patients receiving maintenance biologic therapy are eligible, provided their recurrence is documented more than 6 months from completion of primary cytotoxic chemotherapy (includes maintenance chemotherapy) and a minimum of 3 weeks has elapsed since their last infusion of biologic therapy at the start of protocol intervention, day 1. * Patients must be, after evaluation by the investigator, appropriate candidates for the administration of 5 to 6 cycles of standard platinum-based combination chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, or carboplatin and gemcitabine) following CRS with or without HIPEC. * Bone marrow function: * Hemoglobin ≥ 8.5 g/dL. * Absolute neutrophil count (ANC) ≥ 1,000/mm3. * Platelets ≥ 100,000/mm3. * Renal function: * Creatinine ≤ 1.5mg/dl * Hepatic function: * Bilirubin ≤ 1.5 times ULN. * ALT ≤ 3 times the ULN. * AST ≤ 3 times the ULN. * Neurologic function: * Peripheral neuropathy ≤ CTC AE grade 2. * Blood coagulation parameters: * PT with an INR of ≤ 1.5 and a PTT ≤ 1.5 times the ULN. For patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT \<1.2 times the ULN. * Patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to CRS and must be practicing an effective form of contraception during the study period. Inclusion Criteria for Eligibility Post-Surgery: * Patients will be consented prior to the surgical evaluation/cytoreductive surgery. Patients must have less than or equal to 0.5cm residual disease at the completion of the secondary surgery to be eligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| determine the proportion of patients who are without evidence of disease progression | 24 months | A proportion of patients ≥ 40%, who are without evidence of disease progression at 24 months, is considered acceptable, whereas a proportion of ≤ 25% is considered not acceptable in this patient population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the toxicity and postoperative complications rate | 4 weeks post op | The safety endpoint of our trial is to determine toxicity and postoperative complication rates in both arms using NCI Common Terminology Criteria for Adverse Events version 4.0. and MSKCC Surgical Secondary Events Grading System for complications. |
| determine the completion rate of four cycles | 5 years | A secondary analysis of estimating the completion rate will be conducted. The completion rate and a 95% confidence interval will be calculated for each arm separately. Completion is defined as patients being able to complete ≥ 4 out of 5 or 6 cycles of a standard systemic chemotherapy. |
| pharmacokinetics | 5 years | in a subset of patients randomized to receive HIPEC in the OR. In patients randomized to HIPEC, peritoneal fluid and blood samples only from MSKCC patients will be drawn before, during and after the HIPEC procedure. |
Countries
United States
Outcome results
None listed