Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Carcinoma
Both
Non Small Cell Lung Carcinoma
Trial Information
Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Inclusion Criteria:
- Clinical diagnosis of non-small cell lung cancer
- Non-small cell lung cancer that is not curable with surgery, radiation, or combined
modality chemoradiation
- Failed two prior chemotherapy regimens which must have included platinum
- Measurable disease
Exclusion Criteria:
- Treatment with more than two prior chemotherapy regimens
- History of bone marrow transplantation or stem cell support
- Pregnant or lactating women
- Known history of prior gefitinib therapy
- Known history of prior TLK286 therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
TLK286.3020
NCT ID:
NCT00080340
Start Date:
Completion Date:
May 2005
Related Keywords:
- Non Small Cell Lung Carcinoma
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| Midwestern Regional Medical Center | Zion, Illinois 60099 |
| Texas Oncology, P.A. | Dallas, Texas 75246 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| Cooper Cancer Institute | Camden, New Jersey 08103 |
| Southern California Permanente Medical Group | Downey, California 90242 |
| Dakota Cancer Institute | Fargo, North Dakota 58103-4940 |
| Carolinas Hematology-Oncology Associates | Charlotte, North Carolina 28203 |
| Montefiore Medical Center | Bronx, New York 10467-2490 |
| Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
| Arlington Cancer Center | Arlington, Texas 76012 |
| Duluth Clinic | Duluth, Minnesota 55805 |
| Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
| Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Deerpath Medical Associates | Lake Forest, Illinois 60045 |
| North Shore Oncology Hematology Associates | Libertyville, Illinois 60048 |
| Midwest Cancer Research Group, Inc. | Skokie, Illinois 60077 |
| Missouri Cancer Associates | Columbia, Missouri 65201 |
| Cancer Care Center | New Albany, Indiana 47150 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| Morton Plant Hospital | Clearwater, Florida 33756 |
| Lakeland Regional Medical Center | Lakeland, Florida 33804 |
| Sharp Memorial Hospital | San Diego, California 92123 |
| Highlands Oncology Group | Springdale, Arkansas 72764 |
| Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
| Florida Oncology Associates | Orange Park, Florida 32073 |
| LaPorte Hospital | LaPorte, Indiana 46350-0250 |
| Saint Joseph's Regional Medical Center | South Bend, Indiana 46634-1935 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Regional Hematology Oncology Associates | Durham, North Carolina 27704 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
| Central Jersey Oncology Center | New Brunswick, New Jersey 08901 |
| New York Oncology Hematology, P.C. | Albany, New York 12208 |
| Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| East Tennessee Oncology/Hematology, P.C. | Knoxville, Tennessee 37920 |
| Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
| Broward Oncology Associates | Ft. Lauderdale, Florida 33308 |
| Baptist Hospital of East Tennessee | Knoxville, Tennessee 37920 |
| Northwest Medical Specialties, PLLC | Tacoma, Washington 98405 |
| The Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| Providence Holy Cross Medical Center | Mission Hills, California 91345 |
| Medical Consultants, PC | Muncie, Indiana 47304 |
| Northwest Medical Specialists, PLLC | Tacoma, Washington 98405 |
| Medical Center of Vincennes | Vincennes, Indiana 47591 |
| Clinical Trials & Research Associates, Inc. | Montebello, California 90640 |
| Bay Area Cancer Research Group | Concord, California 94520 |
| Georgetown University Hospital | Washington, District of Columbia 20007 |
| Annapolis Oncology Center | Annapolis, Maryland 21401 |
| Kansas City Cancer Center | Kansas City, Missouri 64111 |
| Mid Ohio Oncology/Hematology, Inc. | Columbus, Ohio 43213 |
| Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
| Marilyn Norton, M. D. | Chula Vista, California 91911 |
| Sharp Rees-Stealy | La Mesa, California 91942 |
| Grossmont Hospital | La Mesa, California 91942 |
| N. County Oncology Medical | Oceanside, California 92056 |
| Florida Hospital | Orlando, Florida 32803 |
| Florida Hospital Memorial Division, Cancer Care Center | Ormond Beach, Florida 32174 |
| Hematology Oncology Associates of Illinois (HOAI) | Chicago, Illinois 60657 |
| Swedish Covenant Cancer Center | Chicago, Illinois 60625 |
| Cancer Care Specialists of Central IL | Decatur, Illinois 62526 |
| Joliet Oncology-Hematology Associates, Ltd. | Flossmoor, Illinois 60422 |
| Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
| Memorial Hospital | Chattanooga, Tennessee 37404 |
| The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC | Gallatin, Tennessee 37066 |
| Southwest Fort Worth Cancer Center | Fort Worth, Texas 76132 |
| Medical Consultants, Ltd. | Milwaukee, Wisconsin 53215 |
| Kaiser Permanente Northwest Region | Portland, Oregon 97227 |
| Palo Verde Hematology Oncology | Glendale, Arizona 85304 |
| Hematology/Oncology Associates of the Treasure Coast | Port St. Lucie, Florida 34952 |
| Raleigh Hematology Oncology Association | Raleigh, North Carolina 27609 |
| Gaston Hematology & Oncology Associates | Gastonia, North Carolina 28054 |
| Wishard Hospital | Indianapolis, Indiana 46202 |
| Lakeland Hospital | St. Joseph, Michigan 49085 |
| Freeman Health System | Joplin, Missouri 64804 |
| Missouri Baptist Medical Center | Saint Louis, Missouri 63131 |
| UAB CCC Clinical Studies Unit | Birmingham, Alabama 35233-2115 |
| Department of Veterans Affairs Medical Center | Birmingham, Alabama 35233 |
| Little Rock Hematology Oncology Benton | Benton, Arkansas 72015 |
| Heritage Physician Group, Oncology | Hot Springs, Arkansas 71913 |
| East Bay Medical Oncology/Hematology Medical Associates, Inc. | Antioch, California 94509 |
| East Valley Hematology Oncology Medical Group | Burbank, California 91505 |
| Rosalba Rodriquez, M. D. | Chula Vista, California 91911 |
| North Valley Hematology Oncology Group | Mission Hills, California 91345 |
| Oncology Care Medical Associates, Inc. | Montebello, California 90640 |
| Beverly Oncology & Imaging | Montebello, California 90640 |
| Beverly Oncology and Imaging Center, Inc. | Montebello, California 90640 |
| Clinical Trials and Research Associates, Inc. | Montebello, California 60460 |
| Medical Oncology Associates - SD | San Diego, California 92123 |
| East Bay Medical Oncology/Hematology Medcial Associates, Inc. | San leandro, California 94578 |
| Santa Monica Hematology/Oncology | Santa Monica, California 90404 |
| Diablo Valley Oncology & Hematology Medical Group, Inc. | Walnut Creek, California 94598 |
| Medical Oncology & Hematology, P. C. | Hamden, Connecticut 06518 |
| Medical Oncology & Hematology, P.C. | Meriden, Connecticut 06451 |
| Northwestern Connecticut Oncology/Hematology | New Milford, Connecticut 06776 |
| New Milford Hospital | New Milford, Connecticut 06776 |
| Sharon Hospital | Sharon, Connecticut 06069 |
| Charlotte Hungerford Hospital | Torrington, Connecticut 06790 |
| Washington Hospital Center - Washington Cancer Institute | Washington, District of Columbia 20010 |
| Moroose, Reynolds, Castillo, Robinson & Lukeman, MD, PA | Altamonte Springs, Florida 32701 |
| The Center for Hematology/Oncology | Boca Raton, Florida 33486 |
| Joseph DeFelice | Clearwater, Florida 33756 |
| Oncology Physicians | Clearwater, Florida 33761 |
| Hitesh Patel | Clearwater, Florida 33756 |
| Space Coast Medical Associates | Cocoa Beach, Florida 32931 |
| Florida Cancer Speicalists | Fort Myers, Florida 33901 |
| South Florida Oncology Hematology | Hollywood, Florida 33021 |
| University of Florida/Jacksonville Faculty Clinic | Jacksonville, Florida 32209 |
| Shands Jacksonville | Jacksonville, Florida 32209 |
| Mohammad Kamal, M. D. | Ocala, Florida 34471 |
| Ocala Research Institute, Inc. | Ocala, Florida 34480 |
| Hematology & Oncology Consultants, PA | Orlando, Florida 32804 |
| Moroose, Reynolds, Castillo, Robinson & Lukman, MD, PA | Orlando, Florida 32804 |
| Peachtree Hematology & Oncology Consultants, P. C. | Atlanta, Georgia 30309 |
| Straub Clinic & Hospital | Honolulu, Hawaii 96813 |
| Kapiolani Medical Center for Women & Children | Honolulu, Hawaii 96826 |
| Decatur Memorial Hospital/Clinical Research | Decatur, Illinois 62526 |
| St. Mary Medical Center | Galesburg, Illinois 61401 |
| Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
| North Shore Cancer Research Association | Skokie, Illinois 60076 |
| Indiana University-Clarian Health Partners | Indianapolis, Indiana 46202 |
| Veterans Administration | Indianapolis, Indiana 46202 |
| Ball Cancer Center at Forest Ridge Medical Pavilion | New Castle, Indiana 47362 |
| Tricare | Vincennes, Indiana 47591 |
| Genesis Health System | Davenport, Iowa 52803 |
| Kansas City Cancer Center | Kansas City, Kansas 66112 |
| Auerbach Hematology Oncology Associates | Baltimore, Maryland 21237 |
| Associates in Oncology/Hematology, P.C. | Kensington, Maryland 20895 |
| Department of Hematology/Oncology | Worcester, Massachusetts 01608 |
| Saint Vincent Hospital/Worcester Medical Center-Paul Seed, R.Ph.D | Worcester, Massachusetts 01608 |
| Fallon Clinic Pharmacy-Linda Tolf, R.Ph. | Worcester, Massachusetts 01608 |
| St. Joseph Mercy Hospital, Cancer Center, OC 139 | Ann Arbor, Michigan 48106 |
| Sparrow Health System | Lansing, Michigan 48912 |
| Ellis Fischel Cancer Center - University of Missouri Health Care | Columbia, Missouri 65203 |
| Boone Hospital Center | Columbia, Missouri 65201 |
| Freeman Cancer Institute | Joplin, Missouri 64804 |
| Horizons West Medical Group | Scottsbluff, Nebraska 69361 |
| Nevada Cancer Centers | Las Vegas, Nevada 89109 |
| University Hospital | Newark, New Jersey 07103 |
| New Mexico Oncology Hematology Consultants, Ltd. | Albuquerque, New Mexico 87109 |
| New York Oncology Hematology, P. C. | Albany, New York 12208 |
| Business Park Drive | Armonk, New York 10504 |
| Albert Einstein Cancer Center at the Montefiore Medical Park | Bronx, New York 10461 |
| The Jack D. Weiler Hospital of the Albert Einstein College of Medicine | Bronx, New York 10461 |
| North Shore Hematology Oncology Associates, P.C. | East Setauket, New York 11733 |
| Queens Medical Associates | Fresh Meadows, New York 11365 |
| Myrna Sanchez, MD | Malone, New York 12953 |
| Alice Hyde Medical Center | Malone, New York 12953 |
| Raleigh Hematology Oncology Associates | Cary, North Carolina 27511 |
| Carolinas HealthCare System/Carolinas Medical Center | Charlotte, North Carolina 28203 |
| Regional Hematology Oncology Association | Durham, North Carolina 27704 |
| Piedmont Hematology Oncology Associates | Winston Salem, North Carolina 27103 |
| Cancer Treatment & Research Center | Bismarck, North Dakota 58501 |
| Odyssey Research | Bismarck, North Dakota 58501 |
| Case Western Reserve University- University Hospitals of Cleveland | Cleveland, Ohio 44106 |
| Mid Ohio Oncology/Hematology | Columbus, Ohio 43222 |
| Community Health Partners, Ireland Cancer Center | Elyria, Ohio 44035 |
| UHHS Chagrin Highlands - Ireland Cancer Center | Orange Village, Ohio 44122 |
| UHHS Westlake - Ireland Cancer Center | Westlake, Ohio 44145 |
| Vita Hematology Oncology, P.C. | Bethlehem, Pennsylvania 18015 |
| Greater Philadelphia Cancer and Hematology Specialists, PC | Philadelphia, Pennsylvania 19114 |
| Robert Packer Hospital | Sayre, Pennsylvania 18840 |
| Guthrie Clinic | Sayre, Pennsylvania 18840 |
| Medical University of S.C. | Charleston, South Carolina 29425 |
| Chattanooga Oncology & Hemtology Associates, P. C. | Chattanooga, Tennessee 37404 |
| The Consultant Group, P.C. | Franklin, Tennessee 37067 |
| Thompson Oncology Group | Knoxville, Tennessee 37932 |
| Baptist Hospital West | Knoxville, Tennessee 37922 |
| Cumberland Oncology & Hematology | Oak Ridge, Tennessee 37830 |
| Center for Oncology Research and Treatment, PA | Dallas, Texas 75230 |
| Dallas Oncology Consultants, PA | Dallas, Texas 75237 |
| Texas Cancer Associates, LLP | Dallas, Texas 75231 |
| The University of Texas - M. D. Anderson Cancer Center | Houston, Texas 77030 |
| Shore Cancer Center | Nassawadox, Virginia 23413 |
| VLCC-Elkhorn | Elkhorn, Wisconsin 53121 |
| Aurora Health Center-Slinger | Slinger, Wisconsin 53086 |
| VLCC-West Bend | West Bend, Wisconsin 53095 |
