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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

Must not have

New York Heart Association (NYHA) Class II or higher Congestive heart failure

Immune deficiency: Clinically significant primary or acquired immune deficiency (i.e. AIDS or on immunosuppressive medication after organ transplant)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart failure that affects my daily activities.

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I have a significant immune deficiency, like AIDS or due to immunosuppressive medication after an organ transplant.

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My tumor is considered to be of low malignant potential.

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

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I have active acute hepatitis.

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I am currently on IV antibiotics for an infection.

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I have active heart disease, such as unstable chest pain or a positive stress test.

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My blood pressure is above 140/90 and I'm not cleared for surgery.

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I have had a stroke or other brain blood flow problems.

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My surgery showed I have extensive scar tissue inside my abdomen that prevents certain treatments.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

To determine the toxicity and postoperative complications rate

determine the completion rate of four cycles

pharmacokinetics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 29Eligibility criteria met