A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer
Both
Pancreatic Cancer
Trial Information
A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the
pancreas;cancer which is unresectable, locally advanced or metastatic.
Must have evidence of disease (clinical or radiological). Male or female, 18 years or
older. Patients may have received prior radiation treatment for management of local
disease providing that disease progression has been documented.
All toxicities have resolved, and the last fraction of radiation treatment was completed
at least 4 weeks prior to randomization.
Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or
gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
PA.3
NCT ID:
NCT00040183
Start Date:
October 2001
Completion Date:
September 2004
Related Keywords:
- Pancreatic Cancer
- Tarceva, EGFR, erlotinib, OSI-774
- Pancreatic Neoplasms
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
| University Hospitals of Cleveland | Cleveland, Ohio 44106 |
| Green Mountain Oncology Group | Rutland, Vermont 05701 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Baystate Medical Center | Springfield, Massachusetts 01199 |
| Southwest Regional Cancer Center | Austin, Texas 78705 |
| New Britain General Hospital | New Britain, Connecticut 06050 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
| Carle Cancer Center | Urbana, Illinois 61801 |
| Arena Oncology Associates | Great Neck, New York 11021 |
| University of Minnesota | Minneapolis, Minnesota 55455 |
| Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Arizona Clinical Research Center | Tucson, Arizona 85712 |
| Loma Linda University Cancer Institute | Loma Linda, California 92354 |
| Highlands Oncology Group | Springdale, Arkansas 72764 |
| Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
| Southwest Washington Medical Center | Vancouver, Washington 98664 |
| Annapolis Medical Specialists | Annapolis, Maryland 21401 |
| New Hampshire Oncology-Hematology PA | Hooksett, New Hampshire 03106 |
| Oncology of Wisconsin | Glendale, Wisconsin 53212 |
| UCLA Medical Center | Los Angeles, California 90095-7059 |
| Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| Kaiser Permanente | Sacramento, California |
| New England Medical Center | Boston, Massachusetts |
| Metropolitan Hematology/Oncology Medical Group, Inc. | Los Angeles, California 90057 |
| DeQuattro Community Cancer Center | Manchester, Connecticut 06040 |
| Eastern Connecticut Oncology | Norwich, Connecticut 06360-2910 |
| Carl and Dorothy Bennett Cancer Center | Stamford, Connecticut 06902-3628 |
| Oncology Hematology Group of South Florida | Miami, Florida 33176 |
| Ocala Oncology | Ocala, Florida 34474 |
| Tampa General Hospital | Tampa, Florida 33606 |
| Atlanta Cancer Center | Atlanta, Georgia 30342 |
| Onc/Hem Associates of Central Illinois | Peoria, Illinois 61602 |
| Hematology Oncology Associates of Illinois | Skokie, Illinois 60077 |
| University of Iowa Hospital & Clinics | Iowa City, Iowa 52242 |
| University of Kentucky | Lexington, Kentucky 40536-0098 |
| Norton Healthcare, Inc. | Louisville, Kentucky 40202 |
| J Gurtler, Hematology and Oncology | Metairie, Louisiana 70006 |
| Sinai Hospital | Baltimore, Maryland 21215 |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231 |
| St Elizabeth Medical Center | Boston, Massachusetts 01235 |
| Berkshire Hematology & Oncology, PC | Pittsfield, Massachusetts 012018298 |
| Kansas City Oncology and Hematology Group | Kansas City, Missouri 64111 |
| St Barnabas Medical Center | Livingston, New Jersey 07039 |
| New York University School of Medicine | New York, New York 10016 |
| St Luke's-Roosevelt Hospital | New York, New York 10019 |
| Interlakes Oncology & Hematology, P.C. | Rochester, New York 14623 |
| Stony Brook University Hospital | Stony Brook, New York 11794-8174 |
| Odyssey Research Services | Bismarck, North Dakota 58501 |
| Chiles Research Cancer Center | Portland, Oregon 97213-2967 |
| Hematology & Oncolgy Assoc of NE PA | Dunmore, Pennsylvania 18512 |
| Charleston Hematology/Oncology | Charleston, South Carolina 29403 |
| Arlington Cancer Centre | Arlington, Texas 76012 |
| Tyler Hematology Oncology PA | Tyler, Texas 75701 |
| Hematology & Oncology Associates of Virginia, Ltd. | Richmond, Virginia 23226 |
| Western Washington Oncology Inc. | Olympia, Washington 98502 |
