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Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable 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 by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer Clinical research trials and Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic 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 Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer. Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic 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 Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic 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 > "G" Clinical Trials Conditions > Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer  Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
For Condition: stage 4B pancreatic cancer,stage 3 pancreatic cancer,adenocarcinoma of the pancreas,stage 4A pancreatic cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
Details: OBJECTIVES: - Compare the overall survival rate in patients with unresectable locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without erlotinib. - Compare the progression-free survival rate in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Compare the response rate and response duration in patients treated with these regimens. - Compare the nature, severity, and frequency of toxic effects of these regimens in these patients. - Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis with outcome and response in patients treated with these regimens. - Determine the pharmacokinetics of erlotinib in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, extent of disease (locally advanced vs metastatic), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms. - Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 of course 1 only, which lasts 8 weeks, and on days 1, 8, and 15 of all subsequent courses, which last 4 weeks each. Patients also receive 1 of 2 doses of oral erlotinib once daily. - Arm II: Patients receive gemcitabine as in arm I and 1 of 2 doses of oral placebo once daily. Treatment continues in both arms in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, on day 29 of course 1, on day 1 of all subsequent courses, at 4 weeks after study, and then every 12 weeks until disease progression. Patients are followed at 4 weeks and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 11 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the pancreas - Locally advanced or metastatic disease that is considered unresectable - No known CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin less than 2 times upper limit of normal (ULN) - AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present) Renal: - Creatinine less than 1.5 times ULN Cardiovascular: - No uncontrolled high blood pressure - No unstable angina - No congestive heart failure - No myocardial infarction within the past year - No cardiac ventricular arrhythmias requiring medication Gastrointestinal: - No gastrointestinal (GI) tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) - No post-surgical malabsorption characterized by: - Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR - Requires IV hyperalimentation - Pancreatic enzyme supplementation allowed provided that the above criteria are not met Ophthalmic: - No ocular inflammation or infection unless fully treated prior to study - No significant ophthalmologic abnormalities, including the following: - Severe dry eye syndrome - Sjogren's syndrome - Keratoconjunctivitis sicca - Severe exposure keratopathy - Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No serious active infection - No other serious underlying medical, psychological, or geographical condition that would preclude study - No prior allergic reaction to compounds with similar chemical or biologic composition to erlotinib - No other prior malignancy within the past 5 years except cancer in situ or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent biologic therapy or immunotherapy Chemotherapy: - No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine administered concurrently with radiotherapy as a radiosensitizer - No other concurrent cytotoxic chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Chemotherapy - At least 4 weeks since prior radiotherapy and recovered - Prior radiotherapy for local disease allowed if evidence of disease progression has occurred - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 2 weeks since prior major surgery - No concurrent ophthalmic surgery Other: - No prior epidermal growth factor receptor inhibitors - At least 2 weeks since prior investigational drug - No other concurrent investigational drugs during and for at least 30 days after study - No other concurrent anti-cancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MalcolmMoore, Study Chair, Ontario Cancer Institute
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106
United States
Cancer Center at Glens Falls Hospital
Glen Falls, New York, 12801
United States
Churchill Hospital
Oxford, , OX3 7LJ
United Kingdom
Liverpool Hospital
Liverpool, New South Wales, 2170
Australia
Sutter Health West Cancer Research Group
Greenbrae, California, 94904
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Tulane Cancer Center
New Orleans, Louisiana, 70112-2699
United States
Hospital Israelita Albert Einstein
Sao Paulo, , 05651-901
Brazil
Hematology & Oncology Associates of Virginia
Mechanicsville, Virginia, 23116
United States
Hospital Italiano
Buenos Aires, , CP1181ACH
Argentina
Instituto Alexander Fleming
Buenos Aires, , 1426
Argentina
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Canada
Stadtische Kliniken Frankfurt-Hochst
Frankfurt, , DOH-65929
Germany
Austin and Repatriation Medical Centre
Heidelberg, Victoria, 3084
Australia
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Canada
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Tel-Aviv Sourasky Medical Center
Tel Aviv, , 64239
Israel
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
Loma Linda University Cancer Institute
Loma Linda, California, 92354
United States
Queen Mary Hospital
Hong Kong, ,
China
Midwest Oncology Consortium
Kansas City, Missouri, 64111
United States
Century City Hospital
Los Angeles, California, 90067
United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, 92120
United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 97213-2967
United States
Auckland Hospital
Auckland, , 1
New Zealand
St. Spiridon University Hospital
Lasi, , 6600
Romania
New Britain General Hospital
New Britain, Connecticut, 06050-2000
United States
Mid Dakota Clinic, P.C.
Bismark, North Dakota, 58502-5538
United States
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
Ashford Cancer Centre
Ashford, South Australia, 5035
Australia
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Kaplan Hospital
Rehovot, , 76100
Israel
Virchow Klinikum Humboldt Universitaet Berlin
Berlin, , D-13353
Germany
Policlinico - Cattedra di Ematologia
Palermo, , 90100
Italy
Norton Healthcare Pavilion
Louisville, Kentucky, 40202
United States
Princess Royal Hospital
Hull, England, HU8 9HE
United Kingdom
Prince of Wales Hospital
Shatin, New Territories, , NT
Hong Kong
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Canada
Dolnoslaskie Centrum Oncology
Wroclaw, , 53-413
Poland
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Royal South Hants Hospital
Southampton, England, SO14 0YG
United Kingdom
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Australia
Hospital Interzonal De Augudos Euita
Lanus, , 1824
Argentina
Clinica Las Condes
Santiago, ,
Chile
Rabin Medical Center - Beilinson Campus
Petah-Tikva, , 49100
Israel
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Pamela Youde Nethersole Eastern Hospital
Hong Kong, ,
China
Queen Elizabeth Hospital
Woodville, South Australia, 5011
Australia
Hematology Oncology, P.C.
Stamford, Connecticut, 06902
United States
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Nucleo de Oncologia da Bahia
Bahia, , 40170-070
Brazil
Northern Centre for Cancer Treatment
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Southwest Regional Cancer Center
Austin, Texas, 78705
United States
Frankston Hospital
Frankston, Victoria, 3199
Australia
University Hospital - Stony Brook
Stony Brook, New York, 11794-8174
United States
Interlakes Oncology/Hematology PC
Rochester, New York, 14623
United States
Rabin Medical Center - Golda-Hasharon Campus
Petah-Tikva, , 49372
Israel
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
Canada
University Wurzburg
Wurzburg, , D-97070
Germany
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
New Cross Hospital
Wolverhampton, England, WV10 0QP
United Kingdom
Instituto Nac de Cancerologia
Tlalpan, Distrito Federal, 22
Mexico
Highlands Oncology Group
Springdale, Arkansas, 72764
United States
Moffitt Clinic at Tampa General Hospital
Tampa, Florida, 33612-9497
United States
Singapore General Hospital
Singapore, , 168609
Singapore
Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre
Porto Alegre, , 91330-490
Brazil
St. Luke's Cancer Center
Guildford, England, GU2 5XX
United Kingdom
Peter MacCallum Cancer Institute
Melbourne, , 8006
Australia
University Hospital of Heraklion
Iraklion (Heraklion), Crete, 71110
Greece
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Royal Perth Hospital
Perth, Western Australia, 6000
Australia
Hematology-Oncology Association of NE Pennsylvania
Dunmore, Pennsylvania, 18512
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
Berkshire Physicians and Surgeons, P.C.
Pittsfield, Massachusetts, 01201
United States
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
Arlington Cancer Center
Arlington, Texas, 76012
United States
Hospital Churruca
Buenos Aires, , 1437
Argentina
Midwest Cancer Research Group, Inc.
Skokie, Illinois, 60076
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Canada
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois, 60004
United States
Presbyterian Hospital
Charlotte, North Carolina, 28233-3549
United States
Ocala Oncology Center
Ocala, Florida, 34471-5563
United States
Institute of Oncology
Randwick, New South Wales, 2031
Australia
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Hippokration Hospital
THESSALONIKI, , 54642
Greece
Toronto General Hospital
Toronto, Ontario, M4X 1K9
Canada
Haemek Medical Center
Afula, , 18101
Israel
Confidence Medical Center
San Isidro, , 1642
Argentina
Hospital Britanico
Buenos Aires, , 1280
Argentina
National Cancer Centre - Singapore
Singapore, , 169610
Singapore
Medical Consultants
Muncie, Indiana, 47304
United States
Christchurch Hospital
Christchurch, , 1
New Zealand
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Cooper Cancer Institute
Voorhees, New Jersey, 08043
United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135-2997
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Kenmar Research Institute
Los Angeles, California, 90057
United States
Davis, Posteraro, & Wasser, MDs, LLP
Manchester, Connecticut, 06040
United States
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
Universitatsklinik, Saarland
HOMBURG / SAAR, , D-66421
Germany
Algoma District Medical Group
Sault Sainte Marie, Ontario, P6B 1Y5
Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, B3H 2Y9
Canada
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Annapolis Medical Specialists
Annapolis, Maryland, 21401
United States
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, NSW 2310
Australia
David Geffen School of Medicine
Los Angeles, California, 90095-7059
United States
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Canada
Tumor Biology Center at the Albert - Ludwigs University
Freiburg, , D-79106
Germany
Oncology of Wisconsin
Glendale, Wisconsin, 53212
United States
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Institute of Oncology - Bucarest
Bucarest, , RO 72435
Romania
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
New Hampshire Oncology-Hematology PA
Hooksett, New Hampshire, 03106
United States
British Columbia Cancer Agency
Victoria, British Columbia, V8R 6V5
Canada
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
United States
Theagenio Medical Institute
THESSALONIKI, , 540 07
Greece
Belfast City Hospital Trust
Belfast, Northern Ireland, BT9 7AB
United Kingdom
Institut Jules Bordet
Brussels, , 1000
Belgium
Saint Bartholomew's Hospital
London, England, EC1A 7BE
United Kingdom
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Sheba Medical Center
Tel Hashomer, , 52621
Israel
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Great Poland Cancer Center
Poznan, , 61 866
Poland
Clinical County Hospital of Sibiu
Sibiu, , 2400
Romania
Guy's and St. Thomas' Hospitals NHS Trust
London, England, SE1 9RT
United Kingdom
Oncology & Hematology Associates of West Broward
Tamarac, Florida, 33321
United States
Arena Oncology Associates
Great Neck, New York, 11021
United States
Southwest Washington Medical Center
Vancouver, Washington, 98664
United States
Tuft-New England Medical Center
Boston, Massachusetts, 02111
United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
United States
Instituto de Oncologia Angel H. Roffo
Buenos Aires, , 1417
Argentina
Mountain States Tumor Institute
Boise, Idaho, 83712
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Velindre Hospital
Cardiff, Wales, CF4 7XL
United Kingdom
Tyler Hematology Oncology, P.A.
Tyler, Texas, 75701
United States
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, 29403
United States
Martin Luther Universitaet
Halle, , DOH-06112
Germany
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Ontario Cancer Institute
Toronto, Ontario, M4X 1K9
Canada
Institutul Oncologic-Universitatea de Medicina
Cluj Napoca, , 3400
Romania
Hematology-Oncology Associates
Mount Holly, New Jersey, 08060
United States
Rambam Medical Center
Haifa, , 31096
Israel
North Middlesex Hospital
Edmonton, London, England, NI8 1QX
United Kingdom
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Centro Estatal de Cancerologia
Dviango, , 34000
Mexico
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Australia
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Carle Cancer Center
Urbana, Illinois, 61801
United States
Queen Elizabeth Hospital
Birmingham, England, B18 7QH
United Kingdom
Western Washington Oncology
Olympia, Washington, 98502
United States
National University Hospital
Singapore, , 119074
Singapore
Central Georgia Hematology Oncology, P.C.
Macon, Georgia, 31201
United States
Staten Island University Hospital
Staten Island, New York, 10305
United States
Texas Cancer Care
Ft. Worth, Texas, 76104
United States
Medizinische Universitaetsklinik und Poliklinik
Heidelberg, , D-69115
Germany
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Beth Israel Medical Center
New York City, New York, 10019
United States
Additional Information:
Study ID Numbers: CDR0000069020; CAN-NCIC-PA3,OSI-CAN-NCIC-PA3
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026338
Other Stage 3 Pancreatic Cancer Studies:
1. Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
2. Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer
3. Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed
4. Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
5. Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
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