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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
The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be visible on cross sectional imaging or diagnostic laparoscopy
Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is define as: Amenorrhea >= 12 consecutive months without another cause or For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My peritoneal disease is visible on scans or through a diagnostic procedure.
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I am using effective birth control or my partner is sterile.
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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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I am eligible for PIPAC based on laparoscopy findings, with no major bowel issues, less than 5L of ascites, and not suitable for cytoreduction and HIPEC.
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I have tried at least one chemotherapy and my cancer has gotten worse.
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I have previously received chemotherapy through injection into the abdomen.
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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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My liver function tests are within the required range.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities
Incidence of adverse events
Secondary outcome measures
Cytoreductive surgery rate (Arm 3)
Functional status
PIPAC technical failure rate
+5 more

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
~1940
Fluorouracil
2014
Completed Phase 3
~11540
Mitomycin
2009
Completed Phase 3
~410
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
Doxorubicin
2012
Completed Phase 3
~7940
Irinotecan
2017
Completed Phase 4
~2680
Biopsy
2014
Completed Phase 4
~840

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,203 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,346 Total Patients Enrolled
Thanh H DellingerPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04329494 — Phase 1
Colorectal Cancer Research Study Groups: Arm I (PIPAC, doxorubicin, cisplatin), Arm II (PIPAC, oxaliplatin, leucovorin, fluorouracil), Arm III (PIPAC, mitomycin, FOLFIRI)
Colorectal Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04329494 — Phase 1
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04329494 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential side effects or risks should be expected from Intraperitoneal Chemotherapy?

"The safety of intraperitoneal chemotherapy is graded at 1, signifying that the data supporting both its efficacy and security are neither comprehensive nor conclusive."

Answered by AI

How many people have joined this research endeavor?

"Affirmative. The information posted on clinicaltrials.gov confirms that this trial is actively recruiting patients, having been first announced on August 21st 2020 and recently updated on May 4th 2022. A total of 49 participants need to be enrolled from 5 different sites for the study's completion."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"According to the clinicaltrials.gov page, this trial is accepting patient enrollment and has been since August 21st 2020 with a most recent update occuring on May 4th 2022."

Answered by AI

Could you please elucidate other research findings involving Intraperitoneal Chemotherapy?

"At present, 1545 clinical trials are being conducted on Intraperitoneal Chemotherapy. The majority of these studies (546) is in its third stage while the remainder of them are spread across 85461 medical centres based mostly in Guangzhou, Guangdong."

Answered by AI

In how many locales can this research be accessed?

"This research is being conducted in 5 distinct sites, with Duarte and New york/Greenlawn among them. If you wish to partake in the trial, it is best that your chosen site be close by so as to minimize any travelling demands."

Answered by AI

Is this investigation unprecedented in nature?

"Since its initial 1997 clinical trial, sponsored by Alfacell, Intraperitoneal Chemotherapy has undergone an extensive study process to gain Phase 3 drug approval. Currently there exist 1545 active trials for this medication in 3924 cities and 82 countries worldwide."

Answered by AI

What pathologies are commonly treated using Intraperitoneal Chemotherapy?

"Intraperitoneal Chemotherapy has been utilized to manage myelocytic leukemia, acute lymphoma, and neuroblastoma (nb) in patients."

Answered by AI
~16 spots leftby Dec 2025