Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCCTG-N0341 N0341, NCT00080951

Objectives

Primary

1. Determine the tumor response rate in patients with metastatic colorectal cancer treated with irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as first-line treatment.

Secondary

1. Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with this regimen.
2. Determine the toxicity of this regimen in these patients.
3. Determine the quality of life of patients treated with this regimen.
4. Determine whether UGT1A1 polymorphism is related to toxicity (especially leukopenia, diarrhea, or neutropenia) or response in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Diagnosis of colorectal adenocarcinoma
  • Metastatic disease



• Not curable by surgery or amenable to radiotherapy with curative intent



• Measurable disease
  • Patients with only lesions measuring ≥ 1 cm but < 2 cm must use spiral CT scan for pre- and post-treatment tumor assessments



• No known CNS metastases or carcinomatous meningitis

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent sargramostim (GM-CSF)

Chemotherapy

• At least 6 months since prior adjuvant chemotherapy
• No prior fluorouracil for advanced colorectal cancer
• No prior adjuvant oxaliplatin
• No prior adjuvant irinotecan

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to > 25% of bone marrow

Surgery

• At least 4 weeks since prior major surgery

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• AST ≤ 5 times upper limit of normal (ULN)
• Bilirubin ≤ 0.5 mg/dL above ULN

Renal

• Creatinine ≤ 1.5 times ULN

  OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No unstable angina
• No symptomatic congestive heart failure
• No serious uncontrolled cardiac arrhythmia

Pulmonary

• No prior clinical diagnosis of interstitial lung disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active or uncontrolled infection
• No other concurrent serious illness
• No pre-existing paraesthesias/dysesthesias of ≥ grade 2 that would interfere with function
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas

Expected Enrollment

A total of 50-105 patients will be accrued for this study within 2 years.

Outline

This is a multicenter study.

Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each chemotherapy course, and at the end of treatment.

Patients are followed every 3 months until 5 years after registration.

McWilliams RR, Goetz MP, Morlan BW, et al.: Phase II trial of oxaliplatin/irinotecan/5-fluorouracil/leucovorin for metastatic colorectal cancer. Clin Colorectal Cancer 6 (7): 516-21, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Erlichman, MD, Protocol chair		Ph: 507-284-2511 Email: erlichman.charles@mayo.edu
Matthew Goetz, MD, Protocol co-chair		Ph: 507-284-2511 Email: goetz.matthew@mayo.edu
Matthew Ames, PhD, Protocol co-chair		Ph: 507-284-2511
Robert McWilliams, MD, Protocol co-chair		Ph: 507-284-2511
Muhammad Salim, MD, Protocol co-chair		Ph: 306-766-2203 Email: msalim@scf.sk.ca

Registry Information
Official Title		Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer
Trial Start Date		2004-03-05
Trial Completion Date		2008-02-27
Registered in ClinicalTrials.gov		NCT00080951
Date Submitted to PDQ		2004-02-18
Information Last Verified		2004-08-19
NCI Grant/Contract Number		CA25224

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