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Completed Phase 2 Interventional Results available

Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery

ClinicalTrials.gov ID: NCT01164228

Public ClinicalTrials.gov record NCT01164228. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 11:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer. PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery.

Study identification

NCT ID
NCT01164228
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
87 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 17, 2010 (Actual)
Primary completion
Mar 30, 2020 (Actual)
Completion
Nov 3, 2021 (Actual)
Last update posted
Jun 15, 2023

2010 – 2021

United States locations

U.S. sites
99
U.S. states
22
U.S. cities
80
Facility City State ZIP Site status
UAB Comprehensive Cancer Center Birmingham Alabama 35294 —
Mayo Clinic Scottsdale Scottsdale Arizona 85259-5499 —
Stanford Cancer Center Stanford California 94305-5824 —
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut 06105 —
Tunnell Cancer Center at Beebe Medical Center Lewes Delaware 19958 —
CCOP - Christiana Care Health Services Newark Delaware 19713 —
Mayo Clinic - Jacksonville Jacksonville Florida 32224 —
Winship Cancer Institute of Emory University Atlanta Georgia 30322 —
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise Idaho 83706 —
St. Joseph Medical Center Bloomington Illinois 61701 —
Graham Hospital Canton Illinois 61520 —
Memorial Hospital Carthage Illinois 62321 —
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois 60611-3013 —
Hematology and Oncology Associates Chicago Illinois 60611 —
Eureka Community Hospital Eureka Illinois 61530 —
Galesburg Clinic, PC Galesburg Illinois 61401 —
Kellogg Cancer Care Center Highland Park Illinois 60035 —
Provena St. Mary's Regional Cancer Center - Kankakee Kankakee Illinois 60901 —
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville Illinois 60048 —
McDonough District Hospital Macomb Illinois 61455 —
Cancer Care and Hematology Specialists of Chicagoland - Niles Niles Illinois 60714 —
BroMenn Regional Medical Center Normal Illinois 61761 —
Community Cancer Center Normal Illinois 61761 —
Community Hospital of Ottawa Ottawa Illinois 61350 —
Cancer Treatment Center at Pekin Hospital Pekin Illinois 61554 —
Proctor Hospital Peoria Illinois 61614 —
CCOP - Illinois Oncology Research Association Peoria Illinois 61615 —
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois 61615 —
Methodist Medical Center of Illinois Peoria Illinois 61636 —
OSF St. Francis Medical Center Peoria Illinois 61637 —
Illinois Valley Community Hospital Peru Illinois 61354 —
Hematology Oncology Associates - Skokie Skokie Illinois 60076 —
Elkhart General Hospital Elkhart Indiana 46515 —
Howard Community Hospital Kokomo Indiana 46904 —
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana 46350 —
Saint Joseph Regional Medical Center Mishawaka Indiana 46545-1470 —
CCOP - Northern Indiana CR Consortium South Bend Indiana 46601 —
Memorial Hospital of South Bend South Bend Indiana 46601 —
McFarland Clinic, PC Ames Iowa 50010 —
McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa 52501 —
Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa 51101 —
Mercy Medical Center - Sioux City Sioux City Iowa 51102 —
St. Luke's Regional Medical Center Sioux City Iowa 51104 —
Cancer Center of Kansas, PA - Chanute Chanute Kansas 66720 —
Cancer Center of Kansas, PA - Dodge City Dodge City Kansas 67801 —
Cancer Center of Kansas, PA - El Dorado El Dorado Kansas 67042 —
Cancer Center of Kansas - Fort Scott Fort Scott Kansas 66701 —
Cancer Center of Kansas-Independence Independence Kansas 67301 —
Cancer Center of Kansas, PA - Kingman Kingman Kansas 67068 —
Lawrence Memorial Hospital Lawrence Kansas 66044 —
Cancer Center of Kansas, PA - Liberal Liberal Kansas 67901 —
Cancer Center of Kansas, PA - McPherson McPherson Kansas 67460 —
Cancer Center of Kansas, PA - Newton Newton Kansas 67114 —
Cancer Center of Kansas, PA - Parsons Parsons Kansas 67357 —
Cancer Center of Kansas, PA - Pratt Pratt Kansas 67124 —
Cancer Center of Kansas, PA - Salina Salina Kansas 67401 —
Cancer Center of Kansas, PA - Wellington Wellington Kansas 67152 —
Associates in Womens Health, PA - North Review Wichita Kansas 67208 —
Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas 67208 —
Cancer Center of Kansas, PA - Wichita Wichita Kansas 67214 —
CCOP - Wichita Wichita Kansas 67214 —
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas 67214 —
Cancer Center of Kansas, PA - Winfield Winfield Kansas 67156 —
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21231-2410 —
Union Hospital of Cecil County Elkton Maryland 21921 —
Saint Joseph Mercy Cancer Center Ann Arbor Michigan 48106-0995 —
CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan 48106 —
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan 48123-2500 —
Genesys Hurley Cancer Institute Flint Michigan 48503 —
Hurley Medical Center Flint Michigan 48503 —
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan 48236 —
Foote Memorial Hospital Jackson Michigan 49201 —
Borgess Medical Center Kalamazoo Michigan 49001 —
West Michigan Cancer Center Kalamazoo Michigan 49007-3731 —
Bronson Methodist Hospital Kalamazoo Michigan 49007 —
Sparrow Regional Cancer Center Lansing Michigan 48912-1811 —
St. Mary Mercy Hospital Livonia Michigan 48154 —
St. Joseph Mercy Oakland Pontiac Michigan 48341-2985 —
Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan 48060 —
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan 48601 —
Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan 49085 —
Lakeside Cancer Specialists, PLLC Saint Joseph Michigan 49085 —
St. John Macomb Hospital Warren Michigan 48093 —
Mayo Clinic Cancer Center Rochester Minnesota 55905 —
CCOP - Northern New Jersey Hackensack New Jersey 07601 —
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees Township New Jersey 08043 —
Beth Israel Medical Center - Petrie Division New York New York 10003-3803 —
Summa Center for Cancer Care at Akron City Hospital Akron Ohio 44309-2090 —
St. Rita's Medical Center Lima Ohio 45801 —
Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania 17822-0001 —
Geisinger Hazleton Cancer Center Hazleton Pennsylvania 18201 —
Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania 19104-4283 —
Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania 19111-2497 —
UPMC Cancer Centers Pittsburgh Pennsylvania 15232 —
Geisinger Medical Group - Scenery Park State College Pennsylvania 16801 —
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania 18711 —
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota 57117-5039 —
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown West Virginia 26506 —
Medical College of Wisconsin Cancer Center Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01164228, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 15, 2023 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01164228 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →