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Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Previously Treated With Irinotecan

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00016978
Collaborator
(none)
40
Enrollment
24
Locations
1
Arm
1.7
Patients Per Site

Study Details

Study Description

Brief Summary

Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil and leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with irinotecan. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  1. Determine the tumor response rate in patients treated with oxaliplatin, fluorouracil, and leucovorin calcium for metastatic colorectal cancer previously treated with irinotecan.

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

  3. Determine the toxicity of this regimen in this patient population. IV. Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), and Leucovorin (CF) in Patients With Metastatic Colorectal Carcinoma Previously Treated With Irinotecan (CPT-11)
Study Start Date :
Apr 1, 2001
Actual Primary Completion Date :
Jun 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during treatment, and then after the last course of treatment.

Drug: FOLFOX regimen

Drug: fluorouracil

Drug: leucovorin calcium

Drug: oxaliplatin

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Diagnosis of metastatic colorectal adenocarcinoma incurable by surgery or not amenable to radiotherapy with curative intent

    • Progressive disease no more than 3 months after completion of a prior weekly irinotecan, fluorouracil, and leucovorin calcium chemotherapy regimen

    • At least 1 measurable lesion At least 20 mm in at least one dimension

    • No known CNS metastases or carcinomatous meningitis

    PATIENT CHARACTERISTICS:

    • Age: 18 and over

    • Performance status: ECOG 0-2

    • Life expectancy: At least 12 weeks

    • Absolute neutrophil count greater than 2,000/mm3

    • Platelet count at least 100,000/mm3

    • Bilirubin no greater than 0.5 mg/dL above upper limit of normal (ULN)

    • AST no greater than 5 times ULN

    • Creatinine no greater than 1.5 times ULN OR creatinine clearance greater than 60 mL/min

    • No unstable angina No symptomatic congestive heart failure

    • No serious uncontrolled cardiac arrhythmia

    • No active or uncontrolled infection

    • No evidence of other serious illness

    • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:

    • No concurrent sargramostim (GM-CSF)

    • At least 4 weeks since prior chemotherapy

    • No more than 1 prior chemotherapy regimen for advanced colorectal cancer

    • Prior adjuvant chemotherapy allowed

    • No prior radiotherapy to more than 25% of bone marrow

    • At least 4 weeks since prior major surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCOP - Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
    2 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61602
    3 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    4 CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa United States 52403-1206
    5 Oncology Associates of Cedar Rapids Cedar Rapids Iowa United States 52403
    6 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
    7 Siouxland Hematology-Oncology Sioux City Iowa United States 51101-1733
    8 CCOP - Wichita Wichita Kansas United States 67214-3882
    9 CCOP - Ochsner New Orleans Louisiana United States 70121
    10 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    11 CCOP - Duluth Duluth Minnesota United States 55805
    12 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    13 CentraCare Clinic Saint Cloud Minnesota United States 56303
    14 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    15 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68131
    16 Medcenter One Health System Bismarck North Dakota United States 58501
    17 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
    18 Altru Health Systems Grand Forks North Dakota United States 58201
    19 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
    20 CCOP - Sooner State Tulsa Oklahoma United States 74136
    21 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
    22 Rapid City Regional Hospital Rapid City South Dakota United States 57709
    23 CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota United States 57105-1080
    24 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Henry C. Pitot, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00016978
    Other Study ID Numbers:
    • NCI-2012-01859
    • NCCTG-N9946
    • CDR0000068638
    First Posted:
    Mar 11, 2004
    Last Update Posted:
    Feb 5, 2013
    Last Verified:
    Aug 1, 2007
    Keywords provided by National Cancer Institute (NCI)
    stage IV colon cancer
    stage IV rectal cancer
    recurrent colon cancer
    recurrent rectal cancer
    adenocarcinoma of the colon
    adenocarcinoma of the rectum
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Leucovorin
    Fluorouracil
    Oxaliplatin
    Calcium
    Levoleucovorin

    Study Results

    No Results Posted as of Feb 5, 2013