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Alkylating agents

PIPAC for Peritoneal Cancer

Phase 1

Recruiting

Led By Thanh H Dellinger

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2

Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC

Must not have

Arm 2 (colorectal/appendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment

Arm 2 (colorectal/appendiceal): Exclusive total parenteral nutrition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from first pressurized intraperitoneal aerosolized chemotherapy (pipac) procedure, assessed up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects of a new way to give chemotherapy to patients with cancer that has spread to the lining of their abdominal cavity.

Who is the study for?

This trial is for adults with ovarian, uterine, gastric, appendiceal or colorectal cancer that has spread to the abdominal lining. They must have had at least one chemotherapy regimen and be in good enough health for a laparoscopy. Women who can bear children and men with partners of this group must use effective contraception.

What is being tested?

The trial tests PIPAC, a minimally invasive procedure delivering aerosolized chemotherapy directly into the abdomen during laparoscopy. It aims to see if this method reduces side effects compared to traditional methods by using lower doses of drugs like cisplatin and doxorubicin.

What are the potential side effects?

Possible side effects include typical chemotherapy reactions such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, potential organ damage (kidney/liver), hair loss, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer is in the ovary, uterus, stomach, appendix, or colon and has spread to the lining of my abdomen.

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I had hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.

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I can safely undergo a laparoscopy.

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My kidney function, measured by creatinine levels, is within the required range.

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My hepatitis B virus is undetectable with treatment.

Exclusion Criteria

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

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I do not have severe heart, kidney, liver issues, or infections that are not under control.

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I am on exclusive IV nutrition for my colorectal/appendiceal condition.

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I haven't had chemotherapy, surgery, or certain cancer drugs for the required waiting period before joining.

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I am immunocompromised due to medication or a known immune system disease.

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I am on exclusive IV nutrition for my colorectal or appendiceal condition.

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I need a tube for feeding due to a blocked intestine.

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I have severe heart issues or have been hospitalized for COPD or diabetes complications recently.

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I am not taking any experimental cancer treatments.

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I have had aerosol chemotherapy for colorectal or appendiceal cancer.

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I have a known DPD deficiency.

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I have received the highest safe dose of certain chemotherapy drugs for my ovarian, uterine, or gastric cancer.

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I have a blockage in my intestines that needs a tube for feeding or relief.

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I have not taken antibiotics for a major infection within 72 hours before my first dose of the study drug.

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I have fluid in my abdomen due to liver issues and a blood clot in the liver's vein.

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My doctor expects I have less than 6 months to live due to my colorectal/appendiceal cancer.

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My doctor expects I have less than 6 months to live due to my colorectal/appendiceal cancer.

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I couldn't tolerate previous treatments for my colorectal/appendiceal cancer due to severe side effects.

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I am having surgery to remove a tumor and part of my digestive tract at the same time.

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I have fluid in my abdomen due to liver issues and a blood clot in the liver vein.

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My stomach or colorectal cancer has spread beyond the abdominal lining.

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I had a severe allergic reaction to platinum-based cancer drugs.

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My colorectal/appendiceal cancer has worsened after the first two treatments.

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I am having surgery to remove a tumor and part of my digestive tract at the same time.

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I do not have severe heart, kidney, liver issues, or uncontrolled infections.

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I have severe heart issues or have been hospitalized for COPD or diabetes complications recently.

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I have not taken antibiotics for a major infection within 72 hours before my first dose of the study drug.

Select...

I have a weakened immune system due to medication or a known condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from first pressurized intraperitoneal aerosolized chemotherapy (pipac) procedure, assessed up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from first pressurized intraperitoneal aerosolized chemotherapy (pipac) procedure, assessed up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first pressurized intraperitoneal aerosolized chemotherapy (pipac) procedure, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose limiting toxicities

Incidence of adverse events

Secondary study objectives

Functional status

Chromium

Percentage of evaluable patients who have achieved a decrease in Peritoneal Regression Grading Score over successive biopsies

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (PIPAC, mitomycin, FOLFIRI)Experimental Treatment8 Interventions

Patients with colorectal or appendiceal cancer who have undergo at least 4 months (or 8 cycles) of first-line standard of care chemotherapy but have not progressed on second line chemotherapy undergo PIPAC with mitomycin IP. Patients also receive standard of care irinotecan IV over 90 on day 1, leucovorin IV over 30 minutes on day 1, and fluorouracil IV on days 1-2 during weeks 2, 4, 8, 10, 14 and 16. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (PIPAC, oxaliplatin, leucovorin, fluorouracil)Experimental Treatment7 Interventions

Patients with colorectal or appendiceal cancer undergo PIPAC with oxaliplatin IP. For cycles 2 and 3, patients receive leucovorin IV over 10 minutes and fluorouracil IV over 15 minutes 1-24 hours before undergoing PIPAC. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (PIPAC, doxorubicin, cisplatin)Experimental Treatment6 Interventions

Patients with ovarian, uterine, or gastric cancer, undergo PIPAC with doxorubicin IP, followed by cisplatin IP. Treatment repeats every 4-6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Doxorubicin

2012

Completed Phase 3

~8030