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Female Urogenital Diseases and Pregnancy Complications

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Carboplatin

secondary cytoreductive surgery (CRS) with or without carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic combination chemotherapy for recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized intraoperatively to undergo CRS with HIPEC (arm A) or CRS only (arm B) in a manner 1:1. Both arms will receive a standard platinum-based systemic chemotherapy postoperatively (5 cycles in arm A and 6 cycles in arm B). In some patients randomized to HIPEC at MSKCC only , peritoneal fluid and blood samples will be drawn before, during and after the HIPEC procedure.

secondary cytoreductive surgery (CRS) with or without carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic combination chemotherapy for recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized intraoperatively to undergo CRS with HIPEC (arm A) or CRS only (arm B) in a manner 1:1. Both arms will receive a standard platinum-based systemic chemotherapy postoperatively (5 cycles in arm A and 6 cycles in arm B).

Secondary Cytoreductive Surgery

Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

platinum-based systemic chemotherapy postoperatively

Dennis Chi, MD

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.

Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase II Randomized Study: Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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.

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.

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.

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.

Mayo Clinic

Baptist Health South Florida

Hartford HealthCare

University of Pittsburgh

University of Chicago

Memorial Sloan Kettering Cancer Center

Bevacizumab

Vaccines

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

A maximum of 6 doses of the polyvalent-KLH vaccine and OPT-821 will be administered to each patient as per the schedule. Bevacizumab will be administered once every two weeks until week 11 and then once every three weeks according to the schedule. When the 6 vaccinations of the polyvalent-KLH vaccine +OPT821 are completed, patients may still continue to receive bevacizumab on the once every three week schedule.

bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821

Paul Sabbatini, MD

The immune system of the body has the ability to fight and eliminate infections and cancers. Immune treatments, such as in this study, seek to teach the immune system to find and destroy cancer cells. The purpose of this study is to test whether it is safe to treat the cancer with a vaccine and another drug called bevacizumab (also known as Avastin).

Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab

A PILOT STUDY OF A POLYVALENT VACCINE-KLH CONJUGATE + OPT-821 GIVEN IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN SECOND OR GREATER COMPLETE OR PARTIAL CLINICAL REMISSION

Toxicities evaluated by CTCAE version 4.0

when given in the presence of bevacizumab

Patients must have IgM titer \>1:80, or a fourfold increase in prevailing antibody titer if present at baseline. Twenty-one patients would be accrued, and if \>8 of 21 patients should meet these criteria for three or more antigens based on the immune response criteria, the study would be considered positive.

Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5mm.

Genentech, Inc.

Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Paul Sabbatini, MD

Number of Participants With Adverse Events

Percentage of Participants Who Met the Immunogenicity Criteria (>/=3 Antigens) of the Vaccine

Progression-free Survival as Assessed By Multiplex Biomarker Panel of Angiogenesis Markers

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT01767675	Ovarian Cancer Fallopian Tubes... Peritoneal Canc...	Secondary Cytor... Carboplatin Hyp... platinum-based ... platinum-based ...	21 Years -	Memorial Sloan Kettering Cancer Center
Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab	NCT01223235	Fallopian Tubes... Ovarian Cancer Peritoneal Canc...	bevacizumab and...	18 Years -	Memorial Sloan Kettering Cancer Center
Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab	NCT01223235	Fallopian Tubes... Ovarian Cancer Peritoneal Canc...	bevacizumab and...	18 Years -	Memorial Sloan Kettering Cancer Center
Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT01767675	Ovarian Cancer Fallopian Tubes... Peritoneal Canc...	Secondary Cytor... Carboplatin Hyp... platinum-based ... platinum-based ...	21 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for fallopian tubes cancer