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Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Terminated
CT.gov ID
NCT00006015
Collaborator
(none)
26
Enrollment
47
Locations
1
Arm
33.1
Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying combination chemotherapy plus trastuzumab to see how well it works in treating patients with advanced, recurrent, or metastatic colorectal cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the response rate of patients who overexpress HER-2/neu with metastatic colorectal adenocarcinoma who have progressed on at least 1 prior, but no more than 2 prior, chemotherapy regimens for metastatic colorectal cancer treated with fluorouracil, leucovorin calcium, oxaliplatin, and trastuzumab (Herceptin).

  • Determine the time to progression of these patients treated with this regimen.

  • Determine the overall toxicity of this regimen in these patients.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22, followed by oxaliplatin IV over 2 hours on days 1 and 15, and then followed by leucovorin calcium IV over 2 hours on days 1, 8, and 15. Fluorouracil IV is administered at the midpoint of the leucovorin calcium infusion on days 1, 8, and 15. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study Evaluating the Combination of 5-Fluorouracil, Leucovorin, Oxaliplatin, and Herceptin in the Treatment of Patients With Metastatic Colorectal Cancer Who Have Progressed After 5-FU and/or Irinotecan-Containing Therapy
Study Start Date :
May 1, 2000
Actual Primary Completion Date :
Dec 1, 2002
Actual Study Completion Date :
Feb 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination Chemotx

Combination chemotherapy for metastatic colorectal cancer in patients who have disease progression after 5-FU and/or irinotecan-containing therapy

Biological: trastuzumab
4 mg/kg IV infusion Day 1, then weekly 2 mg/kg IV infusion (on Days 8, 15, & 22)
Other Names:
  • Herceptin

    • Drug: fluorouracil
    500 mg/sq m IV push weekly for 3 weeks, followed by a 1 wk break
    Other Names:
  • 5-FU

    • Drug: leucovorin calcium
    500 mg/sq m IV infusion over 2 hours weekly for 3 weeks, then a 1 wk break

    Drug: oxaliplatin
    85 mg/sq m IV infusion over 2 hours Days 1 & 15 of each cycle

    Outcome Measures

    Primary Outcome Measures

    1. Response rate [Every 2 tx cycles]

    2. Time to progression [Every 2 tx cycles]

    3. Overall toxicity [Each cycle during tx]

    Eligibility Criteria

    Criteria

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

    • Histologically confirmed advanced, recurrent, or metastatic colorectal adenocarcinoma

    • Resected CNS metastases stable greater than 1 month after completion of radiotherapy for CNS metastases eligible

    • No existing CNS metastases allowed

    • Measurable disease

    • At least 1 dimension as at least 20 mm with conventional techniques OR

    • At least 10 mm with spiral CT scan

    • No truly nonmeasurable lesions:

    • Bone lesions

    • Leptomeningeal disease

    • Lymphangitis cutis/pulmonis

    • Abdominal masses not confirmed and followed by imaging techniques

    • Cystic lesions

    • Must have progressed on at least 1 prior, but no more than 2 prior, fluorouracil and/or irinotecan containing treatment regimens for metastatic colorectal cancer

    • Must have documented HER-2/neu overexpression by immunohistochemistry staining

    • Staining score at least 2+

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • Not specified
    Hematopoietic:

    • Granulocyte count at least 1,500/mm3

    • Platelet count at least 100,000/mm3

    Hepatic:

    • Bilirubin no greater than 2.0 mg/dL

    • AST no greater than 2.5 times upper limit of normal

    Renal:

    • Creatinine normal OR

    • Creatinine clearance at least 60 mL/min

    Cardiovascular:

    • No history of cardiac ischemia or congestive heart failure

    • LVEF at least 50% by ECG or MUGA

    Other:

    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    • No concurrent second malignancy except nonmelanoma skin cancers or carcinoma in situ of the cervix unless completed therapy and considered to be at less than 30% risk of relapse

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:

    • See Disease Characteristics

    • No prior platinum containing chemotherapy

    • At least 3 weeks since prior chemotherapy and recovered

    • No other concurrent chemotherapy

    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • At least 3 weeks since prior radiotherapy and recovered
    Surgery:
    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Veterans Affairs Medical Center - Birmingham Birmingham Alabama United States 35233-1996
    2 University of California San Diego Cancer Center La Jolla California United States 92093-0658
    3 Veterans Affairs Medical Center - San Francisco San Francisco California United States 94121
    4 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
    5 CCOP - Christiana Care Health Services Wilmington Delaware United States 19899
    6 Lombardi Cancer Center Washington District of Columbia United States 20007
    7 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    8 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
    9 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
    10 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    11 Hematology Oncology Associates of the Quad Cities Bettendorf Iowa United States 52722
    12 Holden Comprehensive Cancer Center Iowa City Iowa United States 52242-1009
    13 Veterans Affairs Medical Center - Togus Togus Maine United States 04330
    14 Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
    15 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    16 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    17 University of Massachusetts Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
    18 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417
    19 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    20 Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri United States 65201
    21 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    22 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    23 University of Nebraska Medical Center Omaha Nebraska United States 68198-7680
    24 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    25 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
    26 Veterans Affairs Medical Center - Buffalo Buffalo New York United States 14215
    27 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    28 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    29 New York Presbyterian Hospital - Cornell Campus New York New York United States 10021
    30 Mount Sinai Medical Center, NY New York New York United States 10029
    31 State University of New York - Upstate Medical University Syracuse New York United States 13210
    32 Veterans Affairs Medical Center - Syracuse Syracuse New York United States 13210
    33 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13217
    34 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    35 Veterans Affairs Medical Center - Durham Durham North Carolina United States 27705
    36 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    37 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    38 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    39 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    40 Rhode Island Hospital Providence Rhode Island United States 02903
    41 University of Tennessee Cancer Institute Memphis Tennessee United States 38103
    42 Veterans Affairs Medical Center - Memphis Memphis Tennessee United States 38104
    43 Green Mountain Oncology Group Bennington Vermont United States 05201
    44 Vermont Cancer Center Burlington Vermont United States 05401-3498
    45 Veterans Affairs Medical Center - White River Junction White River Junction Vermont United States 05009
    46 Veterans Affairs Medical Center - Richmond Richmond Virginia United States 23249
    47 MBCCOP - Massey Cancer Center Richmond Virginia United States 23298-0037

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Jeffrey W. Clark, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006015
    Other Study ID Numbers:
    • CDR0000068024
    • U10CA031946
    • CALGB-89902
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    May 3, 2013
    Last Verified:
    Jun 1, 2011
    Keywords provided by , ,
    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
    Trastuzumab
    Calcium
    Levoleucovorin

    Study Results

    No Results Posted as of May 3, 2013