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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Sunitinib
Sponsored by
ECOG-ACRIN Cancer Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, papillary renal cell carcinoma, clear cell sarcoma of the kidney

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed* renal cell carcinoma of any subtype containing any sarcomatoid features NOTE: *Patients must have a paraffin-embedded tumor specimen from the kidney or metastatic site available for central review and confirmation of tumor histology
  • Measurable advanced disease that is not resectable by surgery
  • Patients with resected or radiated brain metastases or those treated with stereotactic radiation therapy are eligible, provided they have been off steroids for at least 2 weeks

  • More than 2 weeks since prior radiotherapy and recovered

    • Previously irradiated lesions must not be the sole site of disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
  • Serum creatinine clearance ≥ 30 mL/min
  • serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal (ULN; ≤ 5 times ULN in the presence of liver metastases)
  • Total bilirubin ≤ 1.5 times ULN
  • Baseline corrected QT interval < 500 msec on EKG
  • Able to swallow pills
  • Negative pregnancy test
  • Fertile patients must use effective contraception before and during study treatment
  • More than 2 weeks since prior and no concurrent ketoconazole, dexamethasone, dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice
  • Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study

Exclusion Criteria:

  • Collecting duct or medullary carcinoma
  • Prior systemic therapy for metastatic disease. One prior therapeutic regimen with a non-tyrosine kinase inhibitor, such as an mtor inhibitor is allowed. Patients who were randomized to placebo on an adjuvant study are eligible
  • History of stroke within the past 6 months.
  • Pregnant or nursing

  • Clinically significant cardiovascular disease, defined as one of the following:

    • Uncontrolled hypertension (blood pressure > 150/100 mm Hg at the time of enrollment); patients with hypertension and BP ≤ 150/100 mm Hg on stable antihypertensive regimen are eligible
    • History of myocardial infarction or unstable angina within the past 24 weeks
    • New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris
    • Peripheral vascular disease ≥ grade II
  • Ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
  • History of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation > 3 beats in a row)
  • Ongoing atrial fibrillation
  • Pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained at less than or within the normal range with medication
  • Serious concurrent illness or active infection that would jeopardize the ability of the patient to receive study treatment
  • Known HIV

Sites / Locations

  • UAB Comprehensive Cancer Center
  • Mayo Clinic Scottsdale
  • Stanford Cancer Center
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  • Tunnell Cancer Center at Beebe Medical Center
  • CCOP - Christiana Care Health Services
  • Mayo Clinic - Jacksonville
  • Winship Cancer Institute of Emory University
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  • St. Joseph Medical Center
  • Graham Hospital
  • Memorial Hospital
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Hematology and Oncology Associates
  • Eureka Community Hospital
  • Galesburg Clinic, PC
  • Kellogg Cancer Care Center
  • Provena St. Mary's Regional Cancer Center - Kankakee
  • North Shore Oncology and Hematology Associates, Limited - Libertyville
  • McDonough District Hospital
  • Cancer Care and Hematology Specialists of Chicagoland - Niles
  • BroMenn Regional Medical Center
  • Community Cancer Center
  • Community Hospital of Ottawa
  • Cancer Treatment Center at Pekin Hospital
  • Proctor Hospital
  • CCOP - Illinois Oncology Research Association
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
  • Methodist Medical Center of Illinois
  • OSF St. Francis Medical Center
  • Illinois Valley Community Hospital
  • Hematology Oncology Associates - Skokie
  • Elkhart General Hospital
  • Howard Community Hospital
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • Saint Joseph Regional Medical Center
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • McFarland Clinic, PC
  • McCreery Cancer Center at Ottumwa Regional
  • Siouxland Hematology-Oncology Associates, LLP
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Cancer Center of Kansas, PA - Chanute
  • Cancer Center of Kansas, PA - Dodge City
  • Cancer Center of Kansas, PA - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas, PA - Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas, PA - Liberal
  • Cancer Center of Kansas, PA - McPherson
  • Cancer Center of Kansas, PA - Newton
  • Cancer Center of Kansas, PA - Parsons
  • Cancer Center of Kansas, PA - Pratt
  • Cancer Center of Kansas, PA - Salina
  • Cancer Center of Kansas, PA - Wellington
  • Associates in Womens Health, PA - North Review
  • Cancer Center of Kansas, PA - Medical Arts Tower
  • Cancer Center of Kansas, PA - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas, PA - Winfield
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Union Hospital of Cecil County
  • Saint Joseph Mercy Cancer Center
  • CCOP - Michigan Cancer Research Consortium
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Foote Memorial Hospital
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • Sparrow Regional Cancer Center
  • St. Mary Mercy Hospital
  • St. Joseph Mercy Oakland
  • Mercy Regional Cancer Center at Mercy Hospital
  • Seton Cancer Institute at Saint Mary's - Saginaw
  • Lakeland Regional Cancer Care Center - St. Joseph
  • Lakeside Cancer Specialists, PLLC
  • St. John Macomb Hospital
  • Mayo Clinic Cancer Center
  • CCOP - Northern New Jersey
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • Beth Israel Medical Center - Petrie Division
  • Summa Center for Cancer Care at Akron City Hospital
  • St. Rita's Medical Center
  • Geisinger Cancer Institute at Geisinger Health
  • Geisinger Hazleton Cancer Center
  • Abramson Cancer Center of the University of Pennsylvania
  • Fox Chase Cancer Center - Philadelphia
  • UPMC Cancer Centers
  • Geisinger Medical Group - Scenery Park
  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  • Sanford Cancer Center at Sanford USD Medical Center
  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
  • Medical College of Wisconsin Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A (Sunitinib + Gemcitabine)

Arm B (Sunitinib)

Arm Description

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.

Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.

Outcomes

Primary Outcome Measures

Proportion of Patients With Response
Response is defined as either complete response (CR, disappearance of all lesions) or partial response (PR, at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits).

Secondary Outcome Measures

Progression-free Survival
Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as follows: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Overall Survival
Overall survival is defined as the time from randomization to death or date last known alive.

Full Information

First Posted
July 15, 2010
Last Updated
June 13, 2023
Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01164228
Brief Title
Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
Official Title
A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2010 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Primary To evaluate the response rate to sunitinib malate with vs without gemcitabine hydrochloride in patients with advanced renal cell carcinoma with sarcomatoid features. Secondary To evaluate progression-free survival of these patients. To evaluate overall survival of these patients. To describe the toxic effects of both sunitinib malate alone and in combination with gemcitabine hydrochloride in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [clear cell and < 20% sarcomatoid and performance status (PS) 0] vs intermediate risk [20-50% sarcomatoid and PS 0] vs poor risk [non-clear cell or > 50% sarcomatoid or PS 1 or non-clear cell]). Patients are randomized to 1 of 2 treatment arms. Arm A: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Arm B: Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. In both arms, courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year. ACTUAL ACCRUAL: A total of 87 patients (47 in arm A and 40 in arm B) were accrued to this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, papillary renal cell carcinoma, clear cell sarcoma of the kidney

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Sunitinib + Gemcitabine)
Arm Type
Experimental
Arm Description
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Arm Title
Arm B (Sunitinib)
Arm Type
Experimental
Arm Description
Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
2'-Deoxy-2', 2'-difluorocytidine monohydrochloride, Gemzar
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
SU011248 L-Malate salt, SU010398, PHA-290940AD, Sutent, SU011248
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Proportion of Patients With Response
Description
Response is defined as either complete response (CR, disappearance of all lesions) or partial response (PR, at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits).
Time Frame
Assessed every 3 months for 2 years and every 6 months for year 3.
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as follows: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame
Assessed every 3 months for 2 years and every 6 months for year 3.
Title
Overall Survival
Description
Overall survival is defined as the time from randomization to death or date last known alive.
Time Frame
Assessed every 3 months for 2 years and every 6 months for year 3.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed* renal cell carcinoma of any subtype containing any sarcomatoid features NOTE: *Patients must have a paraffin-embedded tumor specimen from the kidney or metastatic site available for central review and confirmation of tumor histology Measurable advanced disease that is not resectable by surgery Patients with resected or radiated brain metastases or those treated with stereotactic radiation therapy are eligible, provided they have been off steroids for at least 2 weeks More than 2 weeks since prior radiotherapy and recovered Previously irradiated lesions must not be the sole site of disease Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Absolute neutrophil count (ANC) ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL (transfusions allowed) Serum creatinine clearance ≥ 30 mL/min serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal (ULN; ≤ 5 times ULN in the presence of liver metastases) Total bilirubin ≤ 1.5 times ULN Baseline corrected QT interval < 500 msec on EKG Able to swallow pills Negative pregnancy test Fertile patients must use effective contraception before and during study treatment More than 2 weeks since prior and no concurrent ketoconazole, dexamethasone, dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study Exclusion Criteria: Collecting duct or medullary carcinoma Prior systemic therapy for metastatic disease. One prior therapeutic regimen with a non-tyrosine kinase inhibitor, such as an mtor inhibitor is allowed. Patients who were randomized to placebo on an adjuvant study are eligible History of stroke within the past 6 months. Pregnant or nursing Clinically significant cardiovascular disease, defined as one of the following: Uncontrolled hypertension (blood pressure > 150/100 mm Hg at the time of enrollment); patients with hypertension and BP ≤ 150/100 mm Hg on stable antihypertensive regimen are eligible History of myocardial infarction or unstable angina within the past 24 weeks New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris Peripheral vascular disease ≥ grade II Ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 History of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation > 3 beats in a row) Ongoing atrial fibrillation Pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained at less than or within the normal range with medication Serious concurrent illness or active infection that would jeopardize the ability of the patient to receive study treatment Known HIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi S. Balzer-Haas, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5824
Country
United States
Facility Name
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Tunnell Cancer Center at Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
St. Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Hematology and Oncology Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Eureka Community Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Galesburg Clinic, PC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Kellogg Cancer Care Center
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Provena St. Mary's Regional Cancer Center - Kankakee
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
Facility Name
North Shore Oncology and Hematology Associates, Limited - Libertyville
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
McDonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Cancer Care and Hematology Specialists of Chicagoland - Niles
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
BroMenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Hospital of Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Cancer Treatment Center at Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois Valley Community Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Hematology Oncology Associates - Skokie
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
McFarland Clinic, PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
McCreery Cancer Center at Ottumwa Regional
City
Ottumwa
State/Province
Iowa
ZIP/Postal Code
52501
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51102
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Cancer Center of Kansas, PA - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, PA - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, PA - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas, PA - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Cancer Center of Kansas, PA - Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas, PA - McPherson
City
McPherson
State/Province
Kansas
ZIP/Postal Code
67460
Country
United States
Facility Name
Cancer Center of Kansas, PA - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas, PA - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas, PA - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, PA - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, PA - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, PA - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Union Hospital of Cecil County
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912-1811
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
St. Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Lakeside Cancer Specialists, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Beth Israel Medical Center - Petrie Division
City
New York
State/Province
New York
ZIP/Postal Code
10003-3803
Country
United States
Facility Name
Summa Center for Cancer Care at Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
St. Rita's Medical Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Geisinger Hazleton Cancer Center
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Geisinger Medical Group - Scenery Park
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Learn more about this trial

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

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