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Alkylating agents

HIPEC + Surgery for Ovarian Cancer (CRS/HIPEC Trial)

Phase 2

Waitlist Available

Led By Teresa Diaz-Montes, M.D.

Research Sponsored by Mercy Medical Center

Eligibility Criteria Checklist

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

Must have

Stage III/IV disease

Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%

Must not have

Active systemic infection that requires use of parenteral antibiotics

History of acute coronary syndromes (ACS), within the last 6 months, according to AHA definitions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing whether a surgery to remove as much of the cancer as possible, followed by a heated chemotherapy treatment, is a safe and effective treatment for ovarian, fallopian tube, and primary peritoneal cancer.

Who is the study for?

This trial is for adults with advanced stage (III/IV) ovarian, fallopian tube, or primary peritoneal cancer who haven't had treatment yet. They should be physically able to handle the procedures and have good organ function. Pregnant women, those with certain heart conditions, prior strokes or other cancers in the last 3 years are excluded.

What is being tested?

The study tests how safe and effective it is to combine cytoreductive surgery (CRS) with heated chemotherapy directly in the abdomen (HIPEC), followed by standard chemo. It's a phase II trial where patients are randomly assigned to treatments at a community hospital.

What are the potential side effects?

Possible side effects include reactions from chemotherapy like nausea, fatigue, hair loss; surgical complications; kidney issues due to medication toxicity; and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My condition is in stage III or IV.

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I am mostly self-sufficient and can carry out daily activities.

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My blood tests show normal white blood cells, platelets, and hemoglobin levels.

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My kidney function is within the normal range.

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After surgery to remove as much cancer as possible, less than 1 cm of cancer remains.

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My cancer originates from the ovary, fallopian tube, or peritoneum.

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My liver tests are within the required range.

Exclusion Criteria

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

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I am currently on IV antibiotics for an infection.

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I had a heart attack or other heart issue in the last 6 months.

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I have moderate to severe heart failure.

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My kidney function is reduced with high creatinine or low clearance.

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I have had a stroke or brain artery disease in the last 6 months.

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My blood pressure is higher than 140/90 and I haven't been cleared for surgery by a heart doctor.

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I am not pregnant or breastfeeding.

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I have active hepatitis and HIV.

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I experience chest pain with normal physical activity.

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I have had surgery to remove as much of the cancer as possible.

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I have had treatment for ovarian, fallopian tube, or peritoneal cancer.

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I have not had any other cancer in the last 3 years.

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My cancer is in the early stages (Stage I or II).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Post-operative complication rates

Secondary study objectives

Assessment of quality of life

Evaluate overall survival

Evaluate the rate of progression free survival

Other study objectives

Risk factors for morbidity and mortality

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CRS/HIPEC with adjuvant IV chemotherapyExperimental Treatment6 Interventions

Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up

Group II: CRS with adjuvant IV/IP chemotherapyActive Control5 Interventions

Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytoreductive Surgery (CRS)

2015

Completed Phase 2

~20

Adjuvant Chemotherapy

2015

Completed Phase 2

~20