Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01688973
First received: September 14, 2012
Last updated: July 18, 2014
Last verified: May 2014
  Purpose

This randomized phase II trial studies how well tivantinib with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Condition Intervention Phase
Childhood Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Type 1 Papillary Renal Cell Carcinoma
Type 2 Papillary Renal Cell Carcinoma
Drug: tivantinib
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate (confirmed complete response or partial response), determined according to Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of toxicities, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Summarized by arm by examining the frequency and severity of toxicities, the frequency and extent of required dose modifications, and the frequency and cause of patient withdrawal for reasons other than progression.

  • PFS [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Role of c-MET [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Explored through the use of Cox regression, categorical analysis (responders/non-responders versus high expressors, etc.), and graphical presentations.

  • Role of EGFR [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Explored through the use of Cox regression, categorical analysis (responders/non-responders versus high expressors, etc.), and graphical presentations.


Estimated Enrollment: 78
Study Start Date: August 2012
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (tivantinib)
Patients receive tivantinib PO BID on days 1-28.
Drug: tivantinib
Given PO
Other Name: ARQ 197
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (tivantinib and erlotinib hydrochloride)
Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28.
Drug: tivantinib
Given PO
Other Name: ARQ 197
Drug: erlotinib hydrochloride
Given PO
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the response rate (confirmed complete and partial response) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 (tivantinib) or ARQ 197 combined with erlotinib (erlotinib hydrochloride).

SECONDARY OBJECTIVES:

I. To assess the progression free survival (PFS) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 or ARQ 197 combined with erlotinib.

II. To assess the safety and tolerability of ARQ 197 therapy and ARQ 197 combined with erlotinib.

III. To descriptively assess the role of prior treatment on outcome.

TERTIARY OBJECTIVES:

I. To bank tissue specimens for future use and once funding is obtained to evaluate the expression of tissue correlative biomarkers such as hepatocyte growth factor receptor (c-MET) and epidermal growth factor receptor (EGFR), and to perform exploratory correlation with clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28.

ARM II: Patients receive tivantinib PO BID and erlotinib hydrochloride PO once daily (QD) on days 1-28.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for up to 2 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic, or locally advanced and unresectable; mixed histologies will be allowed provided that they contain >= 50% of the papillary component
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment form
  • Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
  • Patients with a history of brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levetiracetam, gabapentin)
  • Patients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma; patients must not have received a MET inhibitor or erlotinib as prior therapy; at least 21 days must have elapsed since completion of prior systemic therapy, 42 days for nitrosoureas or mitomycin C; patients must have recovered from all associated toxicities at the time of registration
  • Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 21 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
  • Patients must not be receiving or planning to receive any other investigational agents
  • Patients must have a complete physical examination and medical history within 28 days prior to registration
  • Patients must have a Zubrod performance status of 0-2
  • White blood cell (WBC) >= 2,000/mcL
  • Absolute neutrophil count (ANC) >= 1,000/mcL
  • Platelet count >= 75,000/mcL
  • Serum bilirubin =< 1.5 x institutional upper limits of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) must be =< 1.5 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT/SGPT) must be =< 5 x the institutional ULN
  • Serum creatinine must be =< 2 x the institutional ULN
  • Sodium, potassium and calcium must be obtained within 14 days prior to registration
  • Patients with a known history of the following corneal diseases are not eligible: dry eye syndrome, Sjogren's syndrome, keratoconjunctivitis sicca, exposure keratopathy, Fuchs' dystrophy or other active disorders of cornea
  • Patients known to be human immunodeficiency virus (HIV)-positive and receiving combination anti-retroviral therapy are not eligible
  • Patients must be able to take oral medications; patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease; patients with intractable nausea or vomiting are not eligible
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
  • Patients must be offered the opportunity to participate in specimen banking for future translational medicine studies
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688973

  Hide Study Locations
Locations
United States, Arizona
Arizona Cancer Center at UMC Orange Grove
Tucson, Arizona, United States, 85704
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
Kaiser Anaheim Medical Center
Anaheim, California, United States, 92807
Kaiser Permanente Medical Group - Baldwin Park
Baldwin Park, California, United States, 91706
Kaiser Foundation Hospital
Bellflower, California, United States, 90706
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Mills - Peninsula Hospitals
Burlingame, California, United States, 94010
City of Hope
Duarte, California, United States, 91010
Kaiser Permanente Hospital
Fontana, California, United States, 92335
Kaiser Permanente - Harbor City
Harbor City, California, United States, 90710
Southern California Permanente Medical Group
Irvine, California, United States, 92618
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Kaiser Permanente-West Los Angeles
Los Angeles, California, United States, 90034
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
Fremont - Rideout Cancer Center
Marysville, California, United States, 95901
Sutter Cancer Research Consortium
Novato, California, United States, 94945
Kaiser Permanente - Panorama City
Panorama City, California, United States, 91402
Kaiser Permanente Medical Center
Riverside, California, United States, 92505
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente
San Diego, California, United States, 92120
Kaiser Permanente at San Diego
San Diego, California, United States, 92120
California Pacific Medical Center
San Francisco, California, United States, 94118
Kaiser Permanente Health Care
San Marcos, California, United States, 92069
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Tahoe Forest Cancer Center
Truckee, California, United States, 96161
Sutter Solano Medical Center
Vallejo, California, United States, 94589
Kaiser Permanente
Woodland Hills, California, United States, 91367
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
Idaho Urologic Institute PA
Meridian, Idaho, United States, 83642
United States, Illinois
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Hines Veterans Administration Hospital
Hines, Illinois, United States, 60141
Presence Saint Mary's Hospital
Kankakee, Illinois, United States, 60901
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States, 46237
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States, 67530
Hays Medical Center
Hays, Kansas, United States, 67601
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, United States, 65702
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Providence Medical Center
Kansas City, Kansas, United States, 66112
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Salina Regional Health Center
Salina, Kansas, United States, 67401
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Maryland
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, Michigan
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
University of Michigan
Ann Arbor, Michigan, United States, 48109
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan University Hospital
Ann Arbor, Michigan, United States, 48109
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Truman Medical Center
Kansas City, Missouri, United States, 64108
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States, 07018-1095
United States, New York
Glens Falls Hospital
Glens Falls, New York, United States, 12801
Orange Regional Medical Center
Middletown, New York, United States, 10940
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Columbus CCOP
Columbus, Ohio, United States, 43215
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Dayton CCOP
Dayton, Ohio, United States, 45420
Grandview Hospital
Dayton, Ohio, United States, 45405
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, United States, 78209
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
University Hospital
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Swedish Medical Center-Edmonds
Edmonds, Washington, United States, 98026
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Harborview Medical Center
Seattle, Washington, United States, 98104
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center
Seattle, Washington, United States, 98195
United General Hospital
Sedro-Woolley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Sponsors and Collaborators
Investigators
Principal Investigator: Przemyslaw Twardowski Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01688973     History of Changes
Other Study ID Numbers: NCI-2012-01641, NCI-2012-01641, SWOG-S1107, S1107, S1107, U10CA180888, U10CA032102
Study First Received: September 14, 2012
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014