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Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer
This study is ongoing, but not recruiting participants.
First Received: May 6, 2003   Last Updated: July 23, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response probability [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Study Start Date: May 2003
Detailed Description:

OBJECTIVES:

  • Determine the response (confirmed complete and partial response) in patients with locally advanced or metastatic papillary renal cell cancer treated with erlotinib.
  • Determine the overall survival and 6-month probability of treatment failure in patients treated with this drug.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine, preliminarily, the association of tumor response with tumor expression of epidermal growth factor receptor and status of von Hippel-Lindau gene mutation in patients treated with this drug.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed papillary renal cell cancer, meeting 1 of the following stage criteria:

    • M1 (metastatic disease)
    • M0 with unresectable primary tumor
  • Prior resection of primary tumor allowed

    • Histological confirmation of at least 1 metastatic site of disease required if patients underwent nephrectomy
  • Measurable disease

    • At least 1 unidimensionally measurable lesion
    • Soft tissue disease irradiated within the past 2 months is not considered measurable disease
    • Soft tissue disease irradiated more than 2 months ago must have progressed to be considered measurable with additional measurable disease outside the radiation field
  • No prior or concurrent (treated or untreated) brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if there is liver involvement by tumor)

Renal

  • Creatinine no greater than 2 times ULN

Ophthalmic

  • No known history of any of the following corneal diseases:

    • Dry eye syndrome
    • Sjögren's syndrome
    • Keratoconjunctivitis sicca
    • Exposure keratopathy
    • Fuch's dystrophy
  • No other active disorders of the cornea

Gastrointestinal

  • No gastrointestinal tract disease resulting in an inability to take oral medication
  • No requirement for IV alimentation
  • No active peptic ulcer disease
  • Able to swallow and/or receive enteral medication via gastrostomy feeding tube
  • No intractable nausea or vomiting

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 21 days since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics
  • At least 28 days since prior surgery and recovered
  • No prior surgical procedure affecting absorption

Other

  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060307

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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
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Investigators
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

Additional Information:
Publications:
Pan C, Hussey M, Lara PN, et al.: Encouraging survival with erlotinib in advanced papillary renal cell carcinoma (pRCC): final results from Southwest Oncology Group study 0317. [Abstract] J Clin Oncol 26 (Suppl 15): A-5051, 2008.
Pan C, Hussey M, Lara P, et al.: Phase II trial of the epidermal growth factor receptor (EGFR) inhibitor erlotinib (E) in patients (pts) with advanced papillary renal cell carcinoma (pRCC): SWOG S0317. [Abstract] J Clin Oncol 25 (Suppl 18): A-15516, 651s, 2007.

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

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage IV renal cell cancer
stage III renal cell cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 22, 2009