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

Colorectal Cancer Clinical Trial

Official title:

Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080951
• Other study ID #: NCCTG-N0341
• Secondary ID: NCI-2012-02581CD
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2004
• Last updated: December 5, 2016
• Start date: March 2004
• Est. completion date: February 2008

Study information

• Verified date: December 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, work in 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 II trial to study the effectiveness of combination chemotherapy as first-line therapy in treating patients who have metastatic colorectal cancer.

Description:

OBJECTIVES:

Primary

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

Secondary

• Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with this regimen.

• Determine the toxicity of this regimen in these patients.

• Determine the quality of life of patients treated with this regimen.

• Determine whether UGT1A1 polymorphism is related to toxicity (especially leukopenia, diarrhea, or neutropenia) or response in patients treated with this regimen.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2008
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

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

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• fluorouracil

• irinotecan hydrochloride

• leucovorin calcium

• oxaliplatin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

References & Publications (1)

McWilliams RR, Goetz MP, Morlan BW, Salim M, Rowland KM, Krook JE, Ames MM, Erlichman C. Phase II trial of oxaliplatin/irinotecan/5-fluorouracil/leucovorin for metastatic colorectal cancer. Clin Colorectal Cancer. 2007 May;6(7):516-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response rate		Up to 5 years	No
Secondary	time to progression		Up to 5 years	No
Secondary	overall survival		Up to 5 years	No
Secondary	time to treatment failure		Up to 5 years	No
Secondary	quality of life		Up to 5 years	No