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Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical research trials and Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer. Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer  Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
For Condition: stage 3 pancreatic cancer,stage 4B pancreatic cancer,stage 4A pancreatic cancer
Status: No longer recruiting
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without exatecan mesylate in treating pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer.
Details: OBJECTIVES: - Compare the overall survival of patients with chemotherapy-naive locally advanced or metastatic cancer of the exocrine pancreas treated with exatecan mesylate and gemcitabine versus gemcitabine alone. - Compare the measures of clinical benefit in patients treated with these regimens. - Compare the anti-tumor efficacy of these regimens in this patient population. - Determine the safety profile of exatecan mesylate and gemcitabine in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (60% vs 70-80% vs 90-100%), extent of disease (locally advanced vs metastatic), and prior radiotherapy for pancreatic cancer (yes or no). Patients are randomized to one of two treatment arms. - Arm I: Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes immediately followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive gemcitabine IV over 30 minutes once weekly for up to 7 weeks followed by one week of rest (course 1). For all subsequent courses, patients receive gemcitabine once weekly for 3 weeks followed by one week of rest. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly. PROJECTED ACCRUAL: Approximately 340 patients (170 per treatment arm) will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas - Locally advanced (unresectable) or metastatic disease - No islet cell tumor, lymphoma, or sarcoma of the pancreas - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 5 times ULN - Albumin at least 2.8 g/dL Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No active congestive heart failure - No uncontrolled angina - No myocardial infarction Other: - No serious infection or life-threatening illness unrelated to tumor - No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No overt psychosis or incompetency that would preclude study - No history of a positive serology for HIV - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior systemic anticancer immunotherapy for pancreatic cancer - No concurrent anticancer immunotherapy or other biologic therapy Chemotherapy: - No prior systemic anticancer chemotherapy for pancreatic cancer - Prior fluorouracil as a radiosensitizer allowed - No prior gemcitabine as a radiosensitizer - No other concurrent anticancer chemotherapy Endocrine therapy: - Concurrent megestrol for appetite stimulation allowed Radiotherapy: - At least 28 days since prior radiotherapy and recovered - No prior radiotherapy to more than 25% of estimated bone marrow reserve - No concurrent anticancer radiotherapy Surgery: - At least 28 days since prior major surgery and recovered - No concurrent surgery for cancer Other: - No prior investigational or other systemic anticancer therapy for pancreatic cancer - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326
United States
Nevada Cancer Center
Las Vegas, Nevada, 89109
United States
Harbor Hospital Center
Baltimore, Maryland, 21215-1290
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
Providence Hospital Cancer Center
Southfield, Michigan, 48075
United States
Oncology-Hematology Associates, P.A.
Clinton, Maryland, 20735
United States
HemOnCare, P.C.
Brooklyn, New York, 11235
United States
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43222
United States
Hope Center
Terre Haute, Indiana, 47802
United States
Hematology Oncology Associates
Morristown, New Jersey, 07962
United States
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee, 37404
United States
Great Falls Clinic
Great Falls, Montana, 59405
United States
Family Cancer Center
Germantown, Tennessee, 38138
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6307
United States
Pacific Shores Medical Group
Long Beach, California, 90813
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611-5933
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8174
United States
Central Georgia Hematology Oncology, P.C.
Macon, Georgia, 31201
United States
Peachtree Hematology and Oncology Consultants, P.C.
Atlanta, Georgia, 30309
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Providence Cancer Center
Mobile, Alabama, 36608
United States
California Cancer Care, Inc.
Greenbrae, California, 94904-2007
United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
United States
Center for Cancer And Hematologic Disease
Cherry Hill, New Jersey, 08046
United States
nTouch Research
Melbourne, Florida, 32901
United States
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Scott and White Memorial Hospital
Temple, Texas, 76502
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Williamson Medical Center
Franklin, Tennessee, 37067
United States
Cancer Therapy and Research Center
San Antonio, Texas, 78229-3271
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
United States
Lancaster Cancer Center
Lancaster, Pennsylvania, 17604
United States
Rainier Oncology
Puyallup, Washington, 98372
United States
Yakima Regional Cancer Care Center
Yakima, Washington, 98902
United States
Buffalo Medical Group, P.C.
Williamsville, New York, 14221
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
Summit Medical Group, P.A.
Summit, New Jersey, 07901
United States
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Hematology and Oncology Group
Somerset, New Jersey, 08873
United States
St. Joseph Oncology, Inc.
St. Joseph, Missouri, 64507
United States
Midwest Hematology Oncology Consultants, Ltd.
St. Louis, Missouri, 63136
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-1714
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
UW Cancer Center Wausau Hospital
Wausau, Wisconsin, 54401
United States
Medical Oncology and Hematology, P.C.
Hamden, Connecticut, 06518
United States
CancerCare Manitoba
Winnipeg, Manitoba, R2H 2A6
Canada
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270
United States
Nassau Hematology/Oncology PC
Lake Success, New York, 11042
United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, 84124-1363
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Veterans Affairs Medical Center - San Juan
San Juan, , 00927-5800
Puerto Rico
Medical Oncology/Hematology
Gilroy, California, 95020
United States
CHUM Hopital Saint-Luc
Montreal, Quebec, H2X 3J4
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Canada
New York Medical College
Valhalla, New York, 10595
United States
Intouch Research
Huntsville, Alabama, 35801
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Medical Oncology Associates of Wyoming Valley, P.C.
Kingston, Pennsylvania, 18704-5527
United States
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44111
United States
Billings Oncology Associates
Billings, Montana, 59101
United States
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, 28602
United States
Central Utah Medical Clinic
Provo, Utah, 84604
United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806
United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
United States
Additional Information:
Study ID Numbers: CDR0000068880; DAIICHI-8951A-PRT031,MSKCC-02011
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023972
Other Stage 3 Pancreatic Cancer Studies:
1. Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas
2. Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
3. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
4. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
5. Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other New York Clinical Trials
Other Williamsville Clinical Trials
Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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