Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer
NCT ID: NCT00006015
Last Updated: 2013-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
26 participants
INTERVENTIONAL
2000-05-31
2003-02-28
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination Chemotx
Combination chemotherapy for metastatic colorectal cancer in patients who have disease progression after 5-FU and/or irinotecan-containing therapy
trastuzumab
4 mg/kg IV infusion Day 1, then weekly 2 mg/kg IV infusion (on Days 8, 15, \& 22)
fluorouracil
500 mg/sq m IV push weekly for 3 weeks, followed by a 1 wk break
leucovorin calcium
500 mg/sq m IV infusion over 2 hours weekly for 3 weeks, then a 1 wk break
oxaliplatin
85 mg/sq m IV infusion over 2 hours Days 1 \& 15 of each cycle
Interventions
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trastuzumab
4 mg/kg IV infusion Day 1, then weekly 2 mg/kg IV infusion (on Days 8, 15, \& 22)
fluorouracil
500 mg/sq m IV push weekly for 3 weeks, followed by a 1 wk break
leucovorin calcium
500 mg/sq m IV infusion over 2 hours weekly for 3 weeks, then a 1 wk break
oxaliplatin
85 mg/sq m IV infusion over 2 hours Days 1 \& 15 of each cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Cancer and Leukemia Group B
Principal Investigators
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Jeffrey W. Clark, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Locations
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Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Veterans Affairs Medical Center - Togus
Togus, Maine, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
Green Mountain Oncology Group
Bennington, Vermont, United States
Vermont Cancer Center
Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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Clark JW, Niedzwiecki D, Hollis D, et al.: Phase II trial of 5-fluororuacil (5-FU), leucovorin (LV), oxaliplatin (Ox), and trastuzamab (T) for patients with metastatic colorectal cancer (CRC) refractory to initial therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3584, 2003.
Other Identifiers
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CALGB-89902
Identifier Type: -
Identifier Source: secondary_id
CDR0000068024
Identifier Type: -
Identifier Source: org_study_id
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