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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Arjun Mittra
Study ID
NCT06269978
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Colorectal Carcinoma
  • Metastatic Malignant Neoplasm in the Peritoneum
  • Stage IV Colorectal Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and IP fluid samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Diagnostic Laparoscopy — PROCEDURE
    Undergo diagnostic laparoscopy
  • Fluorouracil — DRUG
    Given via IP infusion
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Oxaliplatin — DRUG
    Given via IP infusion
  • Surgical Procedure — PROCEDURE
    Undergo placement of indwelling IP port

Study Details

This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer.

Key Dates

Start date
Dec 31, 2024
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (oxaliplatin, 5FU)
    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.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Arjun Mittra, MD
614-293-6529
Arjun Mittra, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern/Simmons Cancer CenterDallasTexas75390
Jennifer Knight
[email protected]
(214) 648-7097
Alex Kim, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Ohio State University Comprehensive Cancer Center· Columbus, OHUT Southwestern/Simmons Cancer Center· Dallas, TX

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