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Eniluracil, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Colorectal Cancer
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: New York University School of Medicine
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005050
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: ethynyluracil
Drug: fluorouracil
Drug: oxaliplatin
Phase I
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Fluorouracil 5-Ethynyluracil Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I/II Study of Eniluracil Plus Oral 5-Fluorouracil Combined With Oxaliplatin (FOX-E) in Patients With Previously-Treated Colorectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005050

Locations
United States, New York
Kaplan Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Howard S. Hochster, MD New York University School of Medicine
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067642, NYU-9907, NCI-G00-1718
Study First Received: April 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005050     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:
Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
5-ethynyluracil
Rectal Neoplasm
Intestinal Diseases
Immunosuppressive Agents
Rectal Diseases
Recurrence
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Rectal Cancer
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
5-ethynyluracil
Enzyme Inhibitors
Intestinal Diseases
Immunosuppressive Agents
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Oxaliplatin
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009