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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00060307 |
Purpose
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: erlotinib hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer |
| Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE: Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed papillary renal cell cancer, meeting 1 of the following stage criteria:
Prior resection of primary tumor allowed
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Ophthalmic
No known history of any of the following corneal diseases:
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724 | |
| Banner Good Samaritan Medical Center | |
| Phoenix, Arizona, United States, 85006 | |
| Banner Thunderbird Medical Center | |
| Phoenix, Arizona, United States, 85306 | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006 | |
| St. Joseph's Hospital and Medical Center | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Valley Memorial Hospital | |
| Livermore, California, United States, 94550 | |
| Highland General Hospital at St. George's University School of Medicine | |
| Oakland, California, United States, 94602 | |
| J.C. Robinson, M.D. Regional Cancer Center | |
| San Pablo, California, United States, 94806 | |
| Saint Rose Hospital | |
| Hayward, California, United States, 94545 | |
| Summit Medical Center | |
| Oakland, California, United States, 94609 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609 | |
| United States, Colorado | |
| Exempla Lutheran Medical Center | |
| Wheat Ridge, Colorado, United States, 80033 | |
| McKee Medical Center | |
| Loveland, Colorado, United States, 80539 | |
| Memorial Hospital Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| Montrose Memorial Hospital Cancer Center | |
| Montrose, Colorado, United States, 81401 | |
| North Colorado Medical Center | |
| Greeley, Colorado, United States, 80631 | |
| Poudre Valley Hospital | |
| Fort Collins, Colorado, United States, 80524 | |
| St. Anthony Central Hospital | |
| Denver, Colorado, United States, 80204 | |
| St. Anthony North Hospital | |
| Westminster, Colorado, United States, 80030 | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80217-3364 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, Delaware | |
| Beebe Medical Center | |
| Lewes, Delaware, United States, 19958 | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19718 | |
| St. Francis Hospital | |
| Wilmington, Delaware, United States, 19805 | |
| United States, Florida | |
| Baptist Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Georgia | |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Good Samaritan Regional Health Center | |
| Mt. Vernon, Illinois, United States, 62864 | |
| Saint Anthony's Hospital at Saint Anthony's Health Center | |
| Alton, Illinois, United States, 62002 | |
| United States, Indiana | |
| St. Francis Hospital and Health Centers | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Kansas | |
| Associates in Womens Health | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Cancer Center of Kansas, P.A. - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, P.A. - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, P.A. - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, P.A. - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, P.A. - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, P.A. - Salina | |
| Salina, Kansas, United States, 67042 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Pratt Cancer Center of Kansas | |
| Pratt, Kansas, United States, 67124 | |
| Salina Regional Health Center | |
| Salina, Kansas, United States, 67401 | |
| Cancer Center of Kansas - Winfield Clinic | |
| Winfield, Kansas, United States, 67156 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Baton Rouge General Regional Cancer Center | |
| Baton Rouge, Louisiana, United States, 70806 | |
| Cancer Treatment Center at Christus Schumpert St. Mary Place | |
| Shreveport, Louisiana, United States, 71101 | |
| Mary Bird Perkins Cancer Center - Baton Rouge | |
| Baton Rouge, Louisiana, United States, 70809 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Medical Center of Louisiana - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Union Hospital Cancer Center at Union Hospital | |
| Elkton MD, Maryland, United States, 21921 | |
| United States, Michigan | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Hackley Hospital | |
| Muskegon, Michigan, United States, 49443 | |
| Holland Community Hospital | |
| Holland, Michigan, United States, 49423 | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| Mecosta County General Hospital | |
| Big Rapids, Michigan, United States, 49307 | |
| Metropolitan Hospital | |
| Grand Rapids, Michigan, United States, 49506 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| Spectrum Health Hospital - Blodgett Campus | |
| Grand Rapids, Michigan, United States, 49506 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | |
| Robbinsdale, Minnesota, United States, 55422 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Park Nicollet Health Services | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55403 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| St. Louis, Missouri, United States, 63141 | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| St. Louis, Missouri, United States, 63141 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | |
| Gape Girardeau, Missouri, United States, 63701 | |
| St. Francis Medical Center | |
| Cape Girardeau, Missouri, United States, 63701 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, Montana | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405 | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59107 | |
| Eastern Montana Cancer Center | |
| Miles City, Montana, United States, 59301 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Internal Medicine Associates of Bozeman | |
| Bozeman, Montana, United States, 59715 | |
| Judy L. Schmidt, MD, FACP, P. C. | |
| Missoula, Montana, United States, 59804 | |
| Kalispell Medical Oncology | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59802 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| Sletten Regional Cancer Institute | |
| Great Falls, Montana, United States, 59405 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59802 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Good Samaritan Health Systems | |
| Kearney, Nebraska, United States, 68847 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | |
| Bronx, New York, United States, 10466 | |
| Tucker Center for Cancer Care at Orange Regional Medical Center | |
| Middletown, New York, United States, 10940 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| United States, Ohio | |
| Aultman Hospital Cancer Center at Aultman Health Foundation | |
| Canton, Ohio, United States, 44710 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Cleveland Clinic - Wooster | |
| Wooster, Ohio, United States, 44691 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Community Oncology Group - Independence | |
| Independence, Ohio, United States, 44131 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Institute of Oncology at Vilnius University | |
| Portland, Oregon, United States, 97227 | |
| Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | |
| Portland, Oregon, United States, 97210 | |
| Legacy Meridian Park Hospital | |
| Tualatin, Oregon, United States, 97062 | |
| Legacy Mount Hood Medical Center | |
| Glesham, Oregon, United States, 97030 | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| Providence Milwaukie Hospital | |
| Milwaukie, Oregon, United States, 97222 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| United States, South Carolina | |
| Bon Secours St. Francis Health System | |
| Greenville, South Carolina, United States, 29601 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29304 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| Greenville Hospital System Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | |
| Anderson, South Carolina, United States, 29621 | |
| United States, South Dakota | |
| Avera McKennan Hospital and University Health Center | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center, P. C. | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| American Fork Hospital | |
| American Fork, Utah, United States, 84003 | |
| Cottonwood Hospital Medical Center | |
| Murray, Utah, United States, 84107 | |
| Dixie Regional Medical Center | |
| St. George, Utah, United States, 84770 | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| Logan Regional Hospital | |
| Logan, Utah, United States, 84321 | |
| McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| Utah Cancer Specialists at UCS Cancer Center | |
| Salt Lake City, Utah, United States, 84106 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84603 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
| United States, Washington | |
| Allenmore Hospital | |
| Tacoma, Washington, United States, 98405 | |
| Auburn Regional Center for Cancer Care | |
| Auburn, Washington, United States, 98002 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Capital Medical Center | |
| Olympia, Washington, United States, 98507 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405 | |
| Central Washington Hospital | |
| Wenatchee, Washington, United States, 98801 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| Good Samaritan Cancer Center | |
| Puyallup, Washington, United States, 98372 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98104 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Providence St. Peter Hospital Regional Cancer Center | |
| Olympia, Washington, United States, 95806 | |
| Providence Cancer Center at Holy Family Hospital | |
| Spokane, Washington, United States, 99207 | |
| Providence Cancer Center at Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99204 | |
| Providence Centralia Hospital Regional Cancer Center | |
| Centralia, Washington, United States, 98531 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Skagit Valley Hospital Cancer Care Center | |
| Mt. Vernon, Washington, United States, 98273 | |
| Southwest Washington Medical Center Cancer Center | |
| Vancouver, Washington, United States, 98668 | |
| St. Clare Hospital | |
| Tacoma, Washington, United States, 98499 | |
| St. Francis Hospital | |
| Federal Way, Washington, United States, 98003 | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| St. Joseph Medical Center at Franciscan Health System | |
| Tacoma, Washington, United States, 98405 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98114 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| Wenatchee Valley Clinic | |
| Wenatchee, Washington, United States, 98801 | |
| United States, West Virginia | |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | |
| Parkersburg, West Virginia, United States, 26101 | |
| United States, Wyoming | |
| Welch Cancer Center | |
| Sheridan, Wyoming, United States, 82801 | |
| Investigator: | Michael S. Gordon, MD | Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea |
| Investigator: | Primo N. Lara, MD | University of California, Davis |
| Investigator: | Janice P. Dutcher, MD | Our Lady of Mercy Medical Center Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000301594, SWOG-S0317, ECOG-S0317 |
| Study First Received: | May 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00060307 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent renal cell cancer stage IV renal cell cancer stage III renal cell cancer |
|
Erlotinib Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |