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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fluorouracil
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    irinotecan + oxaliplatin + leucovorin + fluorouracil

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    tumor response rate

    Secondary Outcome Measures

    time to progression
    overall survival
    time to treatment failure
    quality of life

    Full Information

    First Posted
    April 7, 2004
    Last Updated
    December 5, 2016
    Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00080951
    Brief Title
    Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
    Official Title
    Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    April 2005 (Actual)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    irinotecan + oxaliplatin + leucovorin + fluorouracil
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    fluorouracil
    Intervention Type
    Drug
    Intervention Name(s)
    irinotecan hydrochloride
    Intervention Type
    Drug
    Intervention Name(s)
    leucovorin calcium
    Intervention Type
    Drug
    Intervention Name(s)
    oxaliplatin
    Primary Outcome Measure Information:
    Title
    tumor response rate
    Time Frame
    Up to 5 years
    Secondary Outcome Measure Information:
    Title
    time to progression
    Time Frame
    Up to 5 years
    Title
    overall survival
    Time Frame
    Up to 5 years
    Title
    time to treatment failure
    Time Frame
    Up to 5 years
    Title
    quality of life
    Time Frame
    Up to 5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles Erlichman, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17553200
    Citation
    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. doi: 10.3816/CCC.2007.n.017.
    Results Reference
    result

    Learn more about this trial

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

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