Eniluracil, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Colorectal Cancer

March 25, 2011 updated by: NYU Langone Health

A Phase I/II Study of Eniluracil Plus Oral 5-Fluorouracil Combined With Oxaliplatin (FOX-E) in Patients With Previously-Treated Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining eniluracil, fluorouracil, and oxaliplatin in treating patients who have advanced colorectal cancer that has been treated previously.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, and recommended phase II dose of eniluracil, fluorouracil, and oxaliplatin in patients with previously treated advanced colorectal cancer. II. Determine the response rate in patients treated with this regimen.

OUTLINE: This is a dose escalation study of eniluracil and fluorouracil. Patients receive oral eniluracil and oral fluorouracil twice daily on days 1-21. Patients receive oxaliplatin IV over 2 hours on days 1 and 15. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response are treated with 2 more courses and then therapy is stopped. Cohorts of 3-6 patients receive escalating doses of eniluracil and fluorouracil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. The recommended phase II dose (RPTD) is defined as 1 dose level below the MTD. Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for phase I of the study, and an additional 27-40 patients will be accrued for phase II of the study.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Kaplan Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer No more than 2 prior chemotherapy regimens including fluorouracil and/or irinotecan (relapse within 6 months of adjuvant therapy is considered 1 prior regimen) Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN No significant hepatic dysfunction Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: No significant cardiovascular dysfunction Neurologic: No dementia or altered mental status that would preclude informed consent No grade 3 motor or sensory neuropathy No significant neurologic dysfunction Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No malabsorption syndrome or disease significantly affecting gastrointestinal function that would preclude absorption of eniluracil or fluorouracil No active infection requiring systemic therapy within 1 week of study No known platinum allergy No significant endocrine dysfunction

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: No major resection of the stomach or proximal small bowel that would preclude absorption of eniluracil or fluorouracil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Primary Completion (Actual)

June 1, 2001

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

June 7, 2004

First Posted (Estimate)

June 8, 2004

Study Record Updates

Last Update Posted (Estimate)

March 28, 2011

Last Update Submitted That Met QC Criteria

March 25, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067642
  • P30CA016087 (U.S. NIH Grant/Contract)
  • NYU-9907
  • NCI-G00-1718

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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