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

NCT ID: NCT01767675

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-08
• Study Completion Date: 2025-08-26

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.

Conditions

Ovarian Cancer; Fallopian Tubes Cancer; Peritoneal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Secondary Cytoreductive Surgery with HIPEC

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.

Group Type: EXPERIMENTAL

Secondary Cytoreductive Surgery

Intervention Type: PROCEDURE

Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Intervention Type: DRUG

platinum-based systemic chemotherapy postoperatively

Intervention Type: DRUG

5 cycles

Secondary Cytoreductive Surgery without HIPEC

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).

Group Type: EXPERIMENTAL

Secondary Cytoreductive Surgery

Intervention Type: PROCEDURE

platinum-based systemic chemotherapy postoperatively

Intervention Type: DRUG

6 cycles

Interventions

Secondary Cytoreductive Surgery

Intervention Type: PROCEDURE

Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Intervention Type: DRUG

platinum-based systemic chemotherapy postoperatively

5 cycles

Intervention Type: DRUG

platinum-based systemic chemotherapy postoperatively

6 cycles

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

Exclusion Criteria

• Tumors of low malignant potential (borderline carcinomas).
• Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded.
• Patients with a history of primary endometrial cancer are excluded unless the following conditions are met:
• Stage not greater than IA.
• Not a poorly differentiated subtype (including papillary serous, clear cell or other FIGO grade 3 lesions)
• With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies, who had any evidence of the other cancer present within the last 1 year or whose previous cancer treatment contraindicates this protocol therapy, are excluded.
• Subjects with known active acute hepatitis.
• Subjects with active infection that requires parenteral antibiotics.
• Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
• Patients with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment.
• Uncontrolled hypertension defined as > 140/90 and not cleared for surgery at the time of consent..
• New York Heart Association (NYHA) Class II or higher Congestive heart failure.
• History of cerebrovascular disease.
• Immune deficiency: Clinically significant primary or acquired immune deficiency (i.e. AIDS or on immunosuppressive medication after organ transplant).
• Patients with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or places them at an unacceptable risk for participation in the study.
• Patients with known carboplatin or cisplatin allergy.
• Life expectancy < 12 weeks.

• Evidence of extensive intraperitoneal adhesions at the time of surgery, as determined by the operating surgeon which prohibits intraperitoneal therapy.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Baptist Health South Florida

OTHER

Sponsor Role: collaborator

Hartford HealthCare

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Chi, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States

Baptist Health South Florida

Miami, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities, except surgery)

Uniondale, New York, United States

Countries

United States

References

Zivanovic O, Chi DS, Zhou Q, Iasonos A, Konner JA, Makker V, Grisham RN, Brown AK, Nerenstone S, Diaz JP, Schroeder ED, Langstraat CL, Paroder V, Lakhman Y, Soldan K, Su K, Gardner GJ, Andikyan V, Guo J, Jewell EL, Long Roche K, Troso-Sandoval T, Lichtman SM, Moukarzel LA, Dessources K, Abu-Rustum NR, Aghajanian C, Tew WP, Beumer J, Sonoda Y, O'Cearbhaill RE. Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study. J Clin Oncol. 2021 Aug 10;39(23):2594-2604. doi: 10.1200/JCO.21.00605. Epub 2021 May 21.

Reference Type: DERIVED

PMID: 34019431 (View on PubMed)

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

12-275

Identifier Type: -

Identifier Source: org_study_id