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A Multicenter, Open-Label, Randomized, Three-Arm Study Of 5-Fluorouracil (5-FU) Plus Leucovorin (LV) Or Oxaliplatin Or A Combination Of (5-Fu) LV + Oxaliplatin As Second-Line Treatment Of Metastatic Colorectal Carcinoma

Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

A Multicenter, Open-Label, Randomized, Three-Arm Study Of 5-Fluorouracil (5-FU) Plus Leucovorin (LV) Or Oxaliplatin Or A Combination Of (5-Fu) LV + Oxaliplatin As Second-Line Treatment Of Metastatic Colorectal Carcinoma

OBJECTIVES: I. Compare the overall survival of patients with metastatic colorectal carcinoma
treated with fluorouracil and leucovorin calcium with vs without oxaliplatin vs oxaliplatin
alone. II. Compare the response rate, time to tumor-related symptomatic worsening, time to
disease progression, onset and duration of complete and partial responses, and duration of
disease stabilization in patients treated with these regimens. III. Determine the safety
profile of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs
(1 vs 2 or more), and LDH value (up to 1.5 times upper limit of normal (ULN) vs greater than
1.5 times ULN). Patients are randomized to one of three treatment arms. Arm I: Patients
receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22
hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours on day 1. Arm
III: Patients receive oxaliplatin IV concurrently with leucovorin calcium IV over 2 hours
followed by fluorouracil IV continuously over 22 hours on day 1. Leucovorin calcium and
fluorouracil are administered alone on day 2 on the same schedule as on day 1. Treatment
repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable
toxicity. Patients are followed for 30 days, every 2 weeks for up to 3 months, and then
every 3 months thereafter.

PROJECTED ACCRUAL: A total of 786 patients (262 per arm) will be accrued for this study
within 12 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic
adenocarcinoma of the colon or rectum that is not amenable to potentially curative therapy
(e.g., inoperable metastatic disease) At least 1 unidimensionally measurable lesion at
least 20 mm in diameter by conventional CT or MRI scan or at least 10 mm in diameter by
spiral CT scan Progressive disease by CT or MRI scan during or no more than 6 months after
the last dose of prior first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz
regimen) for metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper
limit of normal (ULN) AST and ALT no greater than 2 times ULN (no greater than 5 times ULN
if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater
than 3 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times
ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina, symptomatic
congestive heart failure, or serious cardiac arrhythmia No New York Heart Association
class III or IV heart disease No history of cardiac toxicities with prior fluorouracil and
leucovorin calcium No myocardial infarction within the past 6 months Pulmonary: No
interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception during and for 6 months after study No known dihydropyrimidine dehydrogenase
deficiency No allergy to platinum-containing drugs No history of intolerance to study
anti-emetics (e.g., 5-HT3 antagonists) No known peripheral neuropathy (absence of deep
tendon reflexes as sole deficiency allowed) No uncontrolled diabetes No active infection
No other active malignancy originating from primary site other than colon or rectum

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics One and only 1 prior chemotherapy regimen for metastatic disease
consisting of first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen)
Prior adjuvant fluorouracil with leucovorin calcium allowed At least 3 weeks since prior
chemotherapy for metastatic disease and recovered No prior adjuvant irinotecan No prior
oxaliplatin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to study
lesions unless evidence of progressive disease within the radiotherapy port At least 3
weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since
prior major surgery and recovered Prior surgical resection of primary tumor or metastases
allowed Other: At least 30 days since prior investigational drugs No other concurrent
investigational agents No other concurrent anti-cancer therapy No concurrent participation
in other investigational trials

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mace L. Rothenberg, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 2000

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



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