HIPEC during Surgery for Ovarian Cancer

(HIPEC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Laurel Berry, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Wake Forest University Health Sciences

Must be taking: Platinum chemotherapy

Disqualifiers: Radiation, Adhesive disease, Infection, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it does require that you have completed a specific course of platinum-based chemotherapy before participating.

What data supports the effectiveness of the treatment HIPEC during surgery for ovarian cancer?

Research shows that combining surgery with heated chemotherapy (HIPEC) can be effective for treating cancers in the abdomen, including ovarian cancer, especially in patients who have not responded well to other treatments. This approach has been used successfully in other types of abdominal cancers, suggesting it may help improve outcomes for ovarian cancer patients as well.

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Is HIPEC during surgery for ovarian cancer generally safe for humans?

HIPEC, when combined with surgery, has been associated with significant risks, including long hospital stays and moderate risk of death around the time of surgery. However, some studies suggest that these risks can be reduced with experience and careful management.

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How is the HIPEC treatment with carboplatin during surgery for ovarian cancer different from other treatments?

HIPEC with carboplatin is unique because it involves delivering heated chemotherapy directly into the abdominal cavity during surgery, which can enhance the drug's effectiveness against cancer cells compared to traditional intravenous chemotherapy.

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Eligibility Criteria

This trial is for adults over 18 with specific types of ovarian, fallopian tube, or peritoneal cancer. Participants must have completed certain surgeries and chemotherapy within a set timeframe, have no current evidence of disease, and meet specific health criteria like organ function. Pregnant individuals or those with recent infections, severe allergies to carboplatin, or unstable health conditions are excluded.

Inclusion Criteria

Ability to understand and the willingness to sign an IRB-approved informed consent document

I show no signs of cancer after chemotherapy, confirmed by exams and tests.

My surgery removed all visible cancer before starting chemotherapy.

Exclusion Criteria

You have had allergic reactions to drugs similar to carboplatin.

Pregnancy

I have not had radiation therapy to my abdomen or pelvis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo second look laparoscopy and may receive hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin if visible signs of cancer are present.

Up to 3 months

Follow-up

Participants are monitored for quality of life and toxicities using the FACT-O questionnaire and CTCAE criteria.

Up to 6 months

Participant Groups

The study tests the feasibility and impact on quality of life when administering heated chemotherapy (HIPEC) during a second look laparoscopy surgery in patients who've had prior treatment for certain cancers. The FACT-O questionnaire will assess participants' quality of life outcomes.

Group I: Second Look Laparoscopy and HIPEC with Carboplatin Experimental Treatment 3 Interventions

Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

🇪🇺 Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

🇨🇦 Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, NC

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Aggressive surgical management of peritoneal carcinomatosis with low mortality in a high-volume tertiary cancer center. [2022] Cytoreductive surgery (CS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) for treatment of peritoneal carcinomatosis (PC) traditionally involves high perioperative morbidity and mortality. We report our experience performing CS-HIPEC in a high-volume regional perfusion program designed to limit morbidity and mortality.

2. England pubmed.ncbi.nlm.nih.gov

Cytoreductive surgery and intraperitoneal hyperthermic chemotherapy in the treatment of peritoneal carcinomatosis. [2019] Cytoreductive surgery (CS) and intraperitoneal hyperthermic chemotherapy (IPHC) in the treatment of peritoneal carcinomatosis (PC) in 15 patients are described.

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of peritoneal carcinomatosis by cytoreductive surgery and intraperitoneal hyperthermic chemoperfusion (IHCP): postoperative outcome and risk factors for morbidity. [2022] Cytoreductive surgery with limited or extended peritonectomy associated with intraperitoneal hyperthermic chemoperfusion (IHCP) has been proposed for treatment of peritoneal carcinomatosis (PC) from abdominal neoplasms.

4. Turkey pubmed.ncbi.nlm.nih.gov

A Retrospective Clinical Analysis of Hyperthermic Intraperitoneal Chemotherapy in Gynecological Cancers: Technical Details, Tolerability, and Efficacy. [2022] The aim of this study was to reveal the results of hyperthermic intraperitoneal chemotherapy (HIPEC procedure) performed during cytoreductive surgery (CRS) in patients with endometrial cancer and epithelial ovarian cancer which included mainly platinum-resistant patients.

5. United States pubmed.ncbi.nlm.nih.gov

Reduced morbidity following cytoreductive surgery and intraperitoneal hyperthermic chemoperfusion. [2007] Cytoreductive surgery and intraperitoneal hyperthermic chemoperfusion (IPHC) are an aggressive treatment for patients with peritoneal based malignancies or those with peritoneal dissemination of select histology. Although promising, this therapeutic regimen has been associated with significant morbidity, long hospital stays, and, in some reports, moderate risk for perioperative mortality. Recent experience suggests that these outcomes may be improved.

6. United States pubmed.ncbi.nlm.nih.gov

Intraperitoneal hyperthermic chemotherapy using carboplatin: a phase I analysis in ovarian carcinoma. [2013] Cyclic platinum-based intraperitoneal chemotherapy has proven to be effective after optimal surgical cytoreduction in ovarian carcinoma. Hyperthermia is directly cytotoxic and enhances chemotherapy tumoricidal effects. This study was designed to determine the maximum tolerated dose (MTD) of carboplatin used intraoperatively as intraperitoneal hyperthermic chemotherapy (IPHC), the effect on postoperative systemic chemotherapy administration, and the potential for repeat IPHC at second look surgery.

7. United States pubmed.ncbi.nlm.nih.gov

Cytoreductive surgery followed by intraperitoneal hyperthermic perfusion: analysis of morbidity and mortality in 209 peritoneal surface malignancies treated with closed abdomen technique. [2022] The purpose of this prospective Phase II study was to analyze morbidity and mortality of cytoreductive surgery (CRS) and intraperitoneal hyperthermic perfusion (IPHP) in the treatment of peritoneal surface malignancies.

8. United States pubmed.ncbi.nlm.nih.gov

Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study. [2023] The purpose of this phase II study was to evaluate hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin for recurrent ovarian cancer during secondary cytoreductive surgery.

9. United States pubmed.ncbi.nlm.nih.gov

Results of a multicenter phase I dose-finding trial of hyperthermic intraperitoneal cisplatin after neoadjuvant chemotherapy and complete cytoreductive surgery and followed by maintenance bevacizumab in initially unresectable ovarian cancer. [2022] Hyperthermic intraperitoneal chemotherapy (HIPEC) may improve the outcome of patients with initially unresectable ovarian cancer who are eligible for complete cytoreductive surgery (CCRS) after neoadjuvant chemotherapy. The main objective of this multicenter phase-I study was to identify the recommended dose of cisplatin for HIPEC at CCRS after neoadjuvant carboplatin and paclitaxel (CP).

10. United States pubmed.ncbi.nlm.nih.gov

Morbidity after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with carboplatin used for ovarian, tubal, and primary peritoneal cancer. [2019] Hypertherm intraperitoneal chemotherapy (HIPEC) is increasingly used in the treatment of ovarian, tubal, and primary peritoneal cancer (OC). The aim was to evaluate short-term morbidity of cytoreductive surgery (CRS) and carboplatin HIPEC.