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

Phase 1/Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms



Kaplan Cancer Center New York, New York  10016