HIPEC for Recurrent Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Mazdak Momeni, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Loma Linda University

Must be taking: Platinum-based chemotherapy

Disqualifiers: Invasive malignancies, Coronary artery disease, Hepatitis, Pulmonary disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a phase I prospective study with the primary objective to compare the efficacy and safety of Surgical cytoreduction (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in treatment of recurrent ovarian, primary peritoneal or fallopian tube cancers. Eligible patients consenting to this protocol will undergo their scheduled surgical procedure. After surgical cytoreduction to a residual disease ≤ 2.5 mm, a single dose of carboplatin (800 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen. HIPEC will be continued for 90 minutes in the hyperthermic phase (41°C-43°C). At 4-6 weeks after CRS, patients will go on to receive 6 cycles of standard IV platinum-based chemotherapy. The proportion of patients who are without evidence of recurrence will be assessed at 6, 9, 12 and 18 months after the day of surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research suggests that hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin, used during surgery for recurrent ovarian cancer, may improve outcomes. Studies indicate that HIPEC can provide a survival benefit without causing excessive short-term complications.

^{1 2 3 4 5}

Is HIPEC with carboplatin safe for treating recurrent ovarian cancer?

HIPEC with carboplatin has been studied for safety in treating ovarian cancer, showing some short-term risks like acute kidney injury, especially when combined with extensive surgery. However, it is generally considered safe enough to be used in clinical settings, with ongoing research to better understand and manage these risks.

^{1 2 6 7 8}

How is the HIPEC treatment for recurrent ovarian cancer different from other treatments?

HIPEC for recurrent ovarian cancer is unique because it involves delivering heated chemotherapy directly into the abdominal cavity during surgery, which can enhance the effectiveness of the drug carboplatin by increasing its absorption and targeting cancer cells more directly compared to traditional intravenous chemotherapy.

^{1 2 3 6 9}

Eligibility Criteria

This trial is for adults over 21 with recurrent ovarian, primary peritoneal, or fallopian tube cancers after initial platinum-based chemotherapy. They must have minimal residual disease post-surgery and be in good physical condition. Excluded are those with prior abdominal radiation, other recent cancers, low malignant potential tumors, heart disease, acute hepatitis, severe lung issues, compromised immune systems, known allergies to carboplatin or cisplatin, metastatic disease outside the abdomen or a life expectancy under 3 months.

Inclusion Criteria

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

My organs are functioning properly.

My surgery left 2.5 mm or less of the disease.

Exclusion Criteria

My tumor is considered to be low-grade.

I have active heart artery disease.

I have been diagnosed with acute hepatitis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Cytoreduction and HIPEC

Eligible patients undergo surgical cytoreduction followed by a single dose of carboplatin administered via intraperitoneal hyperthermic perfusion

1 day

1 visit (in-person)

Chemotherapy

Patients receive 6 cycles of standard IV platinum-based chemotherapy starting 4-6 weeks after CRS

18 weeks

Follow-up

Participants are monitored for recurrence-free survival with surveillance CT scans and serum CA-125 levels

18 months

4 visits (in-person) at 6, 9, 12, and 18 months

Participant Groups

The study tests the effectiveness of combining surgical cytoreduction (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) using Carboplatin in patients with recurrent ovarian cancer. After surgery leaving ≤2.5 mm residual disease and HIPEC treatment at high temperatures for 90 minutes follows standard IV platinum-based chemotherapy cycles.

Group I: HIPEC Experimental Treatment 2 Interventions

A procedure in which the internal parts of your abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.

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:

Women's Cancer and Surgical Oncology Center Loma Linda, CA

Who Is Running the Clinical Trial?

Loma Linda University Lead Sponsor

References

1. 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.

2. 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.

3. 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).

4. England pubmed.ncbi.nlm.nih.gov

Calculating the dose of cisplatin that is actually utilized in hyperthermic intraperitoneal chemotherapy among ovarian cancer patients. [2021] Hyperthermic intraperitoneal chemotherapy (HIPEC) is an important treatment for ovarian cancer. A certain portion of cisplatin exits the body via the perfusate at the end of HIPEC, so full-dose utilization cannot be achieved. Herein, we sought to explore how much cisplatin is actually utilized and its prognostic influence.

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

Hyperthermic intraperitoneal chemoperfusion as a component of multimodality therapy for ovarian and primary peritoneal cancer. [2018] The role of hyperthermic intraperitoneal chemoperfusion (HIPEC) in the multimodality treatment of ovarian peritoneal metastases (OPM) and primary peritoneal cancer (PPC) remains controversial. We hypothesized that cytoreductive surgery (CRS) and HIPEC would provide meaningful survival benefit without excessive morbidity.

6. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of concomitant cisplatin and paclitaxel administered by hyperthermic intraperitoneal chemotherapy to patients with peritoneal carcinomatosis from epithelial ovarian cancer. [2018] Hyperthermic intraperitoneal chemotherapy (HIPEC) is advised as a treatment option for epithelial ovarian cancer (EOC) with peritoneal carcinomatosis. This study was designed to define the pharmacokinetics of cisplatin (CDDP) and paclitaxel (PTX) administered together during HIPEC.

7. 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.

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

Extensive Peritonectomy is an Independent Risk Factor for Cisplatin HIPEC-Induced Acute Kidney Injury. [2023] Cisplatin (CDDP)-containing hyperthermic intraperitoneal chemotherapy (HIPEC) is frequently applied in selected patients with peritoneal malignancies derived from ovarian cancer, gastric cancer, and primary peritoneal mesothelioma. HIPEC with CDDP increases perioperative morbidity, in particular by inducing acute kidney injury (AKI). Factors contributing to occurrence of AKI after intraperitoneal perfusion with CDDP have not been sufficiently evaluated.

9. Switzerland pubmed.ncbi.nlm.nih.gov

Survival Outcomes after Hyperthermic Intraperitoneal Chemotherapy for a First Ovarian Cancer Relapse: A Systematic Evidence-Based Review. [2022] Hyperthermic intraperitoneal chemotherapy (HIPEC) is routinely used in the treatment of a first ovarian cancer relapse.