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A Phase II Trial of Eloxatin in Combination With 5-Fluorouracil and Leucovorin in Patients With Advanced Colorectal Carcinoma

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

A Phase II Trial of Eloxatin in Combination With 5-Fluorouracil and Leucovorin in Patients With Advanced Colorectal Carcinoma

OBJECTIVES: I. Evaluate the quantitative and qualitative toxicities of oxaliplatin combined
with fluorouracil and leucovorin calcium in patients with advanced adenocarcinoma of the
colon or rectum.

OUTLINE: Patients receive leucovorin calcium IV over 10-20 minutes followed within 10
minutes by fluorouracil IV bolus on days 1, 8, 15, 29, 36, and 43. Patients receive
oxaliplatin IV over 2 hours prior to leucovorin calcium and fluorouracil on days 1, 15, 29,
and 43. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression
or unacceptable toxicity. Patients with stable or responding disease may receive additional
courses upon approval by the sponsor. Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced adenocarcinoma of the colon or
rectum No prior systemic chemotherapy OR Adjuvant chemotherapy only, completed 6 months
prior to study and with subsequent development of recurrent disease At least 1
bidimensionally measurable lesion No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL (no greater than
5.0 mg/dL if due to intrahepatic biliary obstruction not amenable to biliary
decompression, if approved by the protocol investigator) SGOT no greater than 4 times
upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No
myocardial infarction within the past 6 months No congestive heart failure Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No neurologic disease No active or uncontrolled infection No other
malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ
of the cervix No medical or psychiatric disorders that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for
malignant disease Surgery: Recovered from any prior surgery Other: At least 30 days since
other prior investigational agent No other concurrent investigational agents No concurrent
anticancer agents

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:

January 1999

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016