Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
Conditions
Kidney Cancer
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms
Conditions: 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
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: gemcitabine hydrochloride Type: Drug
Name: sunitinib malate Type: Drug
Overall Status
Recruiting
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 I: 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 II: 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.

PROJECTED ACCRUAL: A total of 100 patients (60 in arm I and 40 in arm II) will be accrued to this study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Histologically confirmed* renal cell carcinoma

- Disease of any subtype allowed

- Disease must have 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

- No collecting duct or medullary carcinoma

- 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

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- AGC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL (transfusions allowed)

- Serum creatinine clearance ≥ 30 mL/min

- SGOT and SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)

- Total bilirubin ≤ 1.5 times ULN

- Baseline QTc interval < 500 msec on EKG

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception before and during study treatment

- Able to swallow pills

- No history of stroke within the past 6 months

- No clinically significant cardiovascular disease, defined as one of the following:

- Uncontrolled hypertension (BP > 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

- NYHA class II-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris

- Peripheral vascular disease ≥ grade II

- No ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by NCI CTCAE version 4

- No patients with a history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation > 3 beats in a row)

- No patients with ongoing atrial fibrillation

- No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained at less than or within the normal range with medication

- No serious concurrent illness or active infection that would jeopardize the ability of the patient to receive study treatment

- No known HIV

- 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

PRIOR CONCURRENT THERAPY:

- No prior systemic therapy for metastatic disease

- Patients who were randomized to placebo on an adjuvant study are eligible

- More than 2 weeks since prior radiotherapy and recovered

- Previously irradiated lesions must not be the sole site of disease

- 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

- Topical and inhaled steroids are allowed
Locations
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Status: Recruiting
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center - 205-934-0309
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Status: Recruiting
Contact: Clinical Trials Office - All Mayo Clinic Locations - 507-538-7623
Stanford Cancer Center
Stanford, California, United States
Status: Recruiting
Contact: Clinical Trials Office - Stanford Cancer Center - 650-498-7061 - cctoffice@stanford.edu
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
Status: Recruiting
Contact: Clinical Trials Office - Tunnell Cancer Center - 302-645-3171
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Status: Recruiting
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services - 302-623-4450
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Status: Recruiting
Contact: Clinical Trials Office - All Mayo Clinic Locations - 507-538-7623
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Clinical Trials Office - Winship Cancer Institute - 404-778-1900
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Status: Recruiting
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center - 208-367-7954
St. Joseph Medical Center
Bloomington, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-662-3311
Graham Hospital
Canton, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-647-5240
Memorial Hospital
Carthage, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 217-357-3131
Hematology and Oncology Associates
Chicago, Illinois, United States
Status: Recruiting
Contact: Clinical Trails Office - Hematology and Oncology Associates - 312-695-1301
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Status: Recruiting
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer - 312-695-1301 - cancer@northwestern.edu
Eureka Community Hospital
Eureka, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-467-2371
Galesburg Clinic, PC
Galesburg, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-344-1000
Kellogg Cancer Care Center
Highland Park, Illinois, United States
Status: Recruiting
Contact: Timothy M. Kuzel, MD - 312-695-4544
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, United States
Status: Recruiting
Contact: Timothy M. Kuzel, MD - 312-695-4544
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States
Status: Recruiting
Contact: Timothy M. Kuzel, MD - 312-695-4544
McDonough District Hospital
Macomb, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-833-4101
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, United States
Status: Recruiting
Contact: Timothy M. Kuzel, MD - 312-695-4544
BroMenn Regional Medical Center
Normal, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-454-1400
Community Cancer Center
Normal, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-451-8500
Community Hospital of Ottawa
Ottawa, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 815-433-3100
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-353-0512
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-243-3605
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Status: Recruiting
Contact: Clinical Trials Office - Methodist Medical Center of Illinois - 309-243-3000
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-243-3000
OSF St. Francis Medical Center
Peoria, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-655-2000
Proctor Hospital
Peoria, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 309-691-1000
Illinois Valley Community Hospital
Peru, Illinois, United States
Status: Recruiting
Contact: Nguyet A. Le-Lindqwister - 815-223-3000
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States
Status: Recruiting
Contact: Timothy M. Kuzel, MD - 312-695-4544
Elkhart General Hospital
Elkhart, Indiana, United States
Status: Recruiting
Contact: Jose A. Bufill, MD, FACP - 574-234-5123
Howard Community Hospital
Kokomo, Indiana, United States
Status: Recruiting
Contact: Jose A. Bufill, MD, FACP - 574-234-5123
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Status: Recruiting
Contact: Jose A. Bufill, MD, FACP - 574-234-5123
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Status: Recruiting
Contact: Jose A. Bufill, MD, FACP - 574-234-5123
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Status: Recruiting
Contact: Jose A. Bufill, MD, FACP - 574-234-5123
Memorial Hospital of South Bend
South Bend, Indiana, United States
Status: Recruiting
Contact: Clinical Trials Office - Memorial Hospital of South Bend - 800-284-7370
McFarland Clinic, PC
Ames, Iowa, United States
Status: Recruiting
Contact: Clinical Trials Office - McFarland Clinic, PC - 515-239-2621
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States
Status: Recruiting
Contact: Robert J. Behrens - 641-684-2946
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
Status: Recruiting
Contact: Donald B. Wender, MD, PhD - 712-252-0088
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Status: Recruiting
Contact: Donald B. Wender, MD, PhD - 712-252-0088
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Status: Recruiting
Contact: Donald B. Wender, MD, PhD - 712-252-0088
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
CCOP - Wichita
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Status: Recruiting
Contact: Shaker R. Dakhil, MD, FACP - 316-262-4467
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Status: Recruiting
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce - 410-955-8804 - jhcccro@jhmi.edu
Union Hospital of Cecil County
Elkton MD, Maryland, United States
Status: Recruiting
Contact: Gregory A. Masters, MD - 302-366-1200
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp - 313-593-8090
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute - 810-762-8057
Hurley Medical Center
Flint, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - Hurley Medical Center - 810-762-8057
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Status: Recruiting
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo - 313-343-3166
Foote Memorial Hospital
Jackson, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Borgess Medical Center
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Raymond S. Lord, MD - 269-373-7458
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Raymond S. Lord, MD - 269-373-7458
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - West Michigan Cancer Center - 269-373-7458
Sparrow Regional Cancer Center
Lansing, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - Sparrow Regional Cancer Center - 517-364-2890
St. Mary Mercy Hospital
Livonia, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Status: Recruiting
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw - 989-776-8411
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Status: Recruiting
Contact: Jose A. Bufill, MD, FACP - 574-234-5123
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
Status: Recruiting
Contact: Jose A. Bufill, MD, FACP - 574-234-5123
St. John Macomb Hospital
Warren, Michigan, United States
Status: Recruiting
Contact: Philip J. Stella, MD - 734-712-1000
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Status: Recruiting
Contact: Clinical Trials Office - All Mayo Clinic Locations - 507-538-7623
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Donna T. McNamara - 201-996-5834
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States
Status: Recruiting
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo - 856-325-6757
Beth Israel Medical Center - Petrie Division
New York, New York, United States
Status: Recruiting
Contact: Clinical Trials Office - Beth Israel Medical Center - Petrie D - 212-844-6286
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Status: Recruiting
Contact: Clinical Trials Office - Akron City Hospital - 330-375-6101
St. Rita's Medical Center
Lima, Ohio, United States
Status: Recruiting
Contact: Clinical Trials Office - St. Rita's Medical Center - 419-226-9617
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Geisinger Cancer Institute - 570-271-5251
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States
Status: Recruiting
Contact: Rajiv Panikkar - 570-459-2901
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers - 800-474-9892
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi - 215-728-4790
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - UPMC Cancer Centers - 412-647-8073
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States
Status: Recruiting
Contact: Rajiv Panikkar - 814-231-4560
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce - 570-271-5251
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Status: Recruiting
Contact: Clinical Trials Office - Sanford Cancer Center - 605-328-1367
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
Status: Recruiting
Contact: Thomas F. Hogan - 304-293-4229
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C - 414-805-4380
Start Date
June 2010
Sponsors
Eastern Cooperative Oncology Group
Source
Eastern Cooperative Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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