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Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer Clinical research trials and Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer. Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer  Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer
Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer
For Condition: Stage 4 rectal cancer,recurrent rectal cancer,stage 4 colon cancer,recurrent colon cancer,adenocarcinoma of the colon,adenocarcinoma of the rectum
Status: Completed
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of combination chemotherapy plus trastuzumab in treating patients who have advanced, recurrent, or metastatic colorectal cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyClark, Study Chair, Massachusetts General Hospital
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Additional Information:
Study ID Numbers: CDR0000068024; CLB-89902
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006015
Other Recurrent Colon Cancer Studies:
1. Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer
2. Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
3. FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen
4. Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
5. Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Related Studies:
Other recurrent colon cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Worcester Clinical Trials
Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer
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