Ovarian CancerPhase 2NCT01767675
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 2 study testing Secondary Cytoreductive Surgery, Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and platinum-based systemic chemotherapy postoperatively in people with Ovarian Cancer and Fallopian Tubes Cancer, run by Memorial Sloan Kettering Cancer Center at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tubes Cancer, Peritoneal Cancer
- What is being tested?
- Secondary Cytoreductive Surgery, Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and platinum-based systemic chemotherapy postoperatively
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 11 sitesUnited States
- Study dates
- 8 Jan 2013to 26 Aug 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 24Show fewer
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
University of Chicago Medical Center
Chicago, Illinois, 60637
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102
Baptist Health South Florida
Miami, Florida, 33143
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
Memorial Sloan Kettering Nassau (All protocol activities, except surgery)
Uniondale, New York, 11553
About this study
Official title: 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
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
- Being tested
- Secondary Cytoreductive Surgery, Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC), platinum-based systemic chemotherapy postoperatively
- Keywords
- Secondary Cytoreductive Surgery, Carboplatin, Hyperthermic Intraperitoneal Chemotherapy (HIPEC), 12-275
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary Cytoreductive SurgeryProcedure or surgery
Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Drug
platinum-based systemic chemotherapy postoperativelyDrug
5 cycles
platinum-based systemic chemotherapy postoperativelyDrug
6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Secondary Cytoreductive Surgery with HIPEC | Experimental | 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. Receives: Procedure: Secondary Cytoreductive Surgery; Drug: Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC); Drug: platinum-based systemic chemotherapy postoperatively |
| Secondary Cytoreductive Surgery without HIPEC | Experimental | 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). Receives: Procedure: Secondary Cytoreductive Surgery; Drug: platinum-based systemic chemotherapy postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
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.
Measured: up to 4 years
Secondary outcomes (3)
Number of Participants Evaluated for Toxicity
Study participants will be evaluated for toxicity with the NCI Common Terminology Criteria for Adverse Events version 4.0. and MSKCC Surgical Secondary Events Grading System for complications.
Measured: 4 weeks post op
Determine the Completion Rate of Four Cycles
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.
Measured: 5 years
Pharmacokinetics for HIPEC Arm Only
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study start8 Jan 2013
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Baptist Health South Florida, Hartford HealthCare, University of Pittsburgh, University of Chicago
- Responsible party
- Sponsor
- Investigators
- Dennis Chi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767675
- Sponsor's protocol ID
- 12-275
- Status last verified
- Aug 2025
- First submitted
- 10 Jan 2013
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 34019431