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Alkylating agents

Surgery + HIPEC for Ovarian Cancer

Phase 2

Waitlist Available

Led By Oliver Zivanovic, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky Performance Status (KPS) of ≥ 70%

Disease-free interval ≤ 30 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is for women who have had surgery to remove all or most of their cancer, but still have cancer in their abdomen.

Who is the study for?

This trial is for adults over 21 with certain types of ovarian, fallopian tube, or primary peritoneal cancer that came back more than 6 months after platinum-based chemo. They should be healthy enough for surgery and more chemo, have a good performance status (able to care for themselves), and not have had other recent cancers or serious health issues like heart disease.Check my eligibility

What is being tested?

The study tests if adding heated chemotherapy directly into the abdomen (HIPEC) during surgery helps treat cancer better. Patients will get this treatment with carboplatin followed by standard platinum-based chemo. Researchers want to see if HIPEC improves outcomes compared to just having surgery and regular chemo.See study design

What are the potential side effects?

Possible side effects include reactions to carboplatin such as allergic responses, blood disorders like low counts of red or white cells, kidney problems from the drug's toxicity, nerve damage presenting as numbness or tingling in extremities, and general risks associated with major surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself but may not be able to do active work.

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My cancer returned within 30 months after treatment.

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My bilirubin levels are within normal limits.

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I am 21 years old or older.

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I am 21 years old or older.

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My ovarian, peritoneal, or fallopian tube cancer has returned more than 6 months after platinum chemotherapy.

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My cancer is one of the specified types of epithelial cell cancers.

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I am mostly able to care for myself.

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My blood tests show normal levels of hemoglobin, neutrophils, and platelets.

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My liver tests are within the required limits.

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My nerve damage does not severely affect my daily activities.

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I agree to join before surgery and will have less than 0.5cm of cancer left after.

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My cancer is one of the specified types of epithelial cell cancer.

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I've been on maintenance biologic therapy, and it's been over 6 months since my primary chemotherapy ended and 3 weeks since my last biologic therapy infusion.

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My kidney function is normal, with creatinine at or below 1.5mg/dl.

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My nerve damage does not severely affect my daily activities.

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My blood clotting levels are within a safe range.

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I consented before surgery and had less than 0.5cm of cancer left after.

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My cancer returned within 30 months after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

determine the proportion of patients who are without evidence of disease progression

Secondary outcome measures

To determine the toxicity and postoperative complications rate

determine the completion rate of four cycles

pharmacokinetics

Trial Design

2Treatment groups

Experimental Treatment

Group I: Secondary Cytoreductive Surgery without HIPECExperimental Treatment2 Interventions

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 II: Secondary Cytoreductive Surgery with HIPECExperimental Treatment3 Interventions

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghOTHER

1,719 Previous Clinical Trials

16,342,242 Total Patients Enrolled

4 Trials studying Ovarian Cancer

193 Patients Enrolled for Ovarian Cancer

University of ChicagoOTHER

1,001 Previous Clinical Trials

817,631 Total Patients Enrolled

4 Trials studying Ovarian Cancer

74 Patients Enrolled for Ovarian Cancer

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,521 Total Patients Enrolled

72 Trials studying Ovarian Cancer

42,869 Patients Enrolled for Ovarian Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01767675 — Phase 2

Ovarian Cancer Research Study Groups: Secondary Cytoreductive Surgery without HIPEC, Secondary Cytoreductive Surgery with HIPEC

Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01767675 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01767675 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA issued approval of Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)?

"Due to the limited efficacy data, Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) was given a rating of 2 out of 3. However, there is existing evidence that it can be safe in certain contexts."

Answered by AI

What evidence exists that demonstrates the efficacy of Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)?

"Since it was first investigated in 2002 by the Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) has been researched over 900 times. Currently 813 studies are active around the world, with a concentration in Miami, Florida."

Answered by AI

Are investigators currently accepting participants for this medical experiment?

"Clinicaltrials.gov confirms that this medical investigation is no longer recruiting individuals, having first been posted on August 1st 2013 and last updated February 23rd 2022. Despite the study being inactive, there are currently 1461 trials actively recruiting participants."

Answered by AI

For what diseases is Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) commonly prescribed?

"Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) has been found to be a viable option for managing lymphoma, non-hodgkin's and advanced sarcoma. It can also be used as an initial treatment strategy in the case of hodgkin disease."

Answered by AI

How many sites are involved in managing this experiment?

"Currently, 11 medical centres are enrolling patients for this trial. These locations include Miami, New york and Uniondale as well as 8 other cities. For your convenience, we advise selecting the closest clinical site to reduce travel requirements if you decide to take part in the programme."

Answered by AI

How many people are joining this study thus far?

"Unfortunately, no longer any room for recruiting new participants. The trial was first published on August 1st 2013 and last modified February 23rd 2021. If you are looking to join other clinical trials, 648 studies related to fever are searching for patients while 813 HIPEC-related experiences need more volunteers."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study

Zivanovic, Oliver, Dennis S. Chi, Qin Zhou, Alexia Iasonos, Jason A. Konner, Vicky Makker, Rachel N. Grisham, et al.. 2021. “Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.00605.

clinicaltrials.govStudy

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

2013. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01767675.

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