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Anti-metabolites

Treatment (oxaliplatin, 5FU) for Colorectal Cancer

Phase 1

Recruiting

Led By Arjun Mittra, MD

Research Sponsored by Arjun Mittra

Eligibility Criteria Checklist

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

Must have

Not previously undergone cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

"This trial is testing the safety and best dosage of giving oxaliplatin and fluorouracil directly into the peritoneal cavity to treat colorectal cancer that has spread there. These drugs are

Who is the study for?

This trial is for adults with colorectal cancer that has spread to the lining of the abdomen (peritoneal metastasis). They should not have had certain previous treatments, must be expected to live at least 6 months, and have good organ function. Women who can bear children need a negative pregnancy test and agree to use contraception.Check my eligibility

What is being tested?

The trial tests intraperitoneal oxaliplatin and fluorouracil's safety, side effects, and best dose. These drugs are given directly into the abdominal space in patients with peritoneal metastases from colorectal cancer. This method is experimental despite both drugs being FDA-approved for colorectal cancer treatment.See study design

What are the potential side effects?

Oxaliplatin may cause nerve damage leading to numbness or tingling in limbs, allergic reactions, nausea, vomiting, diarrhea; Fluorouracil might result in mouth sores, low blood cell counts increasing infection risk or bleeding problems, fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I have not had surgery and heated chemo in the abdomen for colorectal cancer.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney function, measured by creatinine or GFR, is within the normal range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the curve

Clearance

Half-life

+3 more

Secondary outcome measures

Changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin

Modulation of the tumor microenvironment in response to IP 5FU+oxaliplatin

Overall response rate

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (oxaliplatin, 5FU)Experimental Treatment8 Interventions

Patients undergo placement of indwelling IP port for chemotherapy infusion. Patients receive oxaliplatin and 5FU over 1-2 hours via IP infusion on days 1 and 15 of each cycle. Cycles repeat every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo diagnostic laparoscopy, biopsy, CT/MRI, and collection of blood samples at screening and on study and undergo collection of IP fluid samples on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Oxaliplatin

2011

Completed Phase 4

~2560

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Surgical Procedure

2020

Completed Phase 2

~160

Fluorouracil

2014

Completed Phase 3

~11540

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,417 Total Patients Enrolled

Arjun MittraLead Sponsor

Arjun Mittra, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Frequently Asked Questions

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

Are new patients currently being enrolled in this trial?

"As per the information available on clinicaltrials.gov, recruitment for this trial is currently closed. The trial was initially listed on March 1st, 2024, with the latest update made on February 13th of the same year. Although participation is not open presently for this specific study, there are approximately 3396 other research projects that are actively recruiting patients."

Answered by AI

Has the combination of oxaliplatin and 5FU been officially sanctioned by the FDA for medical treatment?

"Given the preliminary nature of this investigation, Treatment (oxaliplatin, 5FU) has been assigned a safety rating of 1 by our team at Power. This score reflects the limited data available supporting both its safety and effectiveness in this Phase 1 trial."

Answered by AI

What are the main goals and purposes of this clinical investigation?

"The primary objective of this research, to be evaluated over a period of about 1 year, is achieving clearance. Secondary aims include evaluating alterations in the composition of peripheral immune cells following treatment with IP 5FU+oxaliplatin by analyzing samples collected at baseline and after four cycles. The data will be mainly descriptive and exploratory due to the limited sample sizes per dosage level. Findings will be presented using descriptive statistics such as means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for categorical data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer

Arjun Mittra 2024. "Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06269978.