- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01164228
Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Uab Comprehensive Cancer Center
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Arizona
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Scottsdale, Arizona, United States, 85259-5499
- Mayo Clinic Scottsdale
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California
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Stanford, California, United States, 94305-5824
- Stanford Cancer Center
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Connecticut
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Hartford, Connecticut, United States, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Delaware
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Lewes, Delaware, United States, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic - Jacksonville
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute of Emory University
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Idaho
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Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Illinois
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Bloomington, Illinois, United States, 61701
- St. Joseph Medical Center
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Canton, Illinois, United States, 61520
- Graham Hospital
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Carthage, Illinois, United States, 62321
- Memorial Hospital
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Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, United States, 60611
- Hematology and Oncology Associates
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Eureka, Illinois, United States, 61530
- Eureka Community Hospital
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Galesburg, Illinois, United States, 61401
- Galesburg Clinic, PC
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Highland Park, Illinois, United States, 60035
- Kellogg Cancer Care Center
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Kankakee, Illinois, United States, 60901
- Provena St. Mary's Regional Cancer Center - Kankakee
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Libertyville, Illinois, United States, 60048
- North Shore Oncology and Hematology Associates, Limited - Libertyville
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Macomb, Illinois, United States, 61455
- Mcdonough District Hospital
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Niles, Illinois, United States, 60714
- Cancer Care and Hematology Specialists of Chicagoland - Niles
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Normal, Illinois, United States, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, United States, 61761
- Community Cancer Center
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Ottawa, Illinois, United States, 61350
- Community Hospital of Ottawa
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Pekin, Illinois, United States, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, United States, 61614
- Proctor Hospital
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Peoria, Illinois, United States, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, United States, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, United States, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, United States, 61354
- Illinois Valley Community Hospital
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Skokie, Illinois, United States, 60076
- Hematology Oncology Associates - Skokie
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Indiana
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Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
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Kokomo, Indiana, United States, 46904
- Howard Community Hospital
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La Porte, Indiana, United States, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, United States, 46545-1470
- Saint Joseph Regional Medical Center
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South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Ames, Iowa, United States, 50010
- McFarland Clinic, PC
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Ottumwa, Iowa, United States, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, United States, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, United States, 51104
- St. Luke's Regional Medical Center
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Kansas
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Chanute, Kansas, United States, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, United States, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, United States, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, United States, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, United States, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, United States, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, United States, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, United States, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, United States, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, United States, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, United States, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, United States, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, United States, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, United States, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, United States, 67214
- CCOP - Wichita
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Wichita, Kansas, United States, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, United States, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, United States, 67156
- Cancer Center of Kansas, PA - Winfield
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Elkton, Maryland, United States, 21921
- Union Hospital of Cecil County
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Michigan
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Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, United States, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, United States, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, United States, 49201
- Foote Memorial Hospital
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, United States, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, United States, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, United States, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, United States, 48154
- St. Mary Mercy Hospital
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Pontiac, Michigan, United States, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, United States, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, United States, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, United States, 49085
- Lakeside Cancer Specialists, PLLC
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Saint Joseph, Michigan, United States, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Warren, Michigan, United States, 48093
- St. John Macomb Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
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Voorhees, New Jersey, United States, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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New York, New York, United States, 10003-3803
- Beth Israel Medical Center - Petrie Division
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Ohio
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Akron, Ohio, United States, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Lima, Ohio, United States, 45801
- St. Rita's Medical Center
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, United States, 18201
- Geisinger Hazleton Cancer Center
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Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Philadelphia, Pennsylvania, United States, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC Cancer Centers
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State College, Pennsylvania, United States, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, United States, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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West Virginia
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Morgantown, West Virginia, United States, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (Sunitinib + Gemcitabine)
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.
|
Given IV
Other Names:
Given PO
Other Names:
|
Experimental: Arm B (Sunitinib)
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.
|
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Patients With Response
Time Frame: Assessed every 3 months for 2 years and every 6 months for year 3.
|
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).
|
Assessed every 3 months for 2 years and every 6 months for year 3.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival
Time Frame: Assessed every 3 months for 2 years and every 6 months for year 3.
|
Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as follows:
|
Assessed every 3 months for 2 years and every 6 months for year 3.
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Overall Survival
Time Frame: Assessed every 3 months for 2 years and every 6 months for year 3.
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Overall survival is defined as the time from randomization to death or date last known alive.
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Assessed every 3 months for 2 years and every 6 months for year 3.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Naomi S. Balzer-Haas, MD, Abramson Cancer Center at Penn Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
- Gemcitabine
Other Study ID Numbers
- E1808
- U10CA021115 (U.S. NIH Grant/Contract)
- NCT01164228 (Registry Identifier: ClinicalTrials.gov)
- NCI-2011-02055 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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