National Cancer Institute at the National Institutes of Health Clinical Trials (PDQ ) Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery Basic Trial Information Trial Description Summary Further Trial Information Eligibility Criteria Trial Contact Information Basic Trial Information Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI, Other CDR0000681614 ECOG-E1808, E1808, NCT01164228 Trial Description 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 Page 1 of 17
cancer that cannot be removed by surgery. Further Study Information 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. Eligibility 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 Page 2 of 17
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 Page 3 of 17
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 Trial Contact Information Trial Lead Organizations/Sponsors Eastern Cooperative Oncology Group National Cancer Institute Naomi S. Balzer-Haas Principal Investigator Trial Sites U.S.A. California Stanford Stanford Cancer Center Sandy Srinivas Ph: 650-498-7061 Email: clinicaltrials@med.stanford.edu Connecticut Hartford Page 4 of 17
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Delaware Lewes Tunnell Cancer Center at Beebe Medical Center Newark Christiana Gynecologic Oncology, LLC Delaware Clinical and Laboratory Physicians Helen F. Graham Cancer Center at Christiana Hospital Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center Regional Hematology/Oncology, PA - Newark Rehoboth Beach Beebe Health Campus Seaford Nanticoke Memorial Hospital Wilmington Christiana Care Health System-Wilmington Hospital District of Columbia Washington Page 5 of 17
Sibley Memorial Hospital Bruce R. Kressel Ph: 202-243-2373 Georgia Atlanta Winship Cancer Institute of Emory University Wayne B. Harris Ph: 404-778-1868 Idaho Boise Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Illinois Bloomington Illinois CancerCare - Bloomington St. Joseph Medical Center Canton Illinois CancerCare - Canton Carbondale Memorial Hospital of Carbondale James L. Wade Ph: 217-876-4740 Email: kcheek@dmhhs.org Carthage Illinois CancerCare - Carthage Centralia Page 6 of 17
Centralia Oncology Clinic James L. Wade Ph: 217-876-4740 Email: kcheek@dmhhs.org Chicago Robert H. Lurie Comprehensive Cancer Center at Northwestern University Timothy M. Kuzel Ph: 312-695-1301 Email: cancer@northwestern.edu Decatur Cancer Care Center of Decatur James L. Wade Ph: 217-876-4740 Email: kcheek@dmhhs.org Decatur Memorial Hospital Cancer Care Institute James L. Wade Ph: 217-876-4740 Email: kcheek@dmhhs.org Effingham Crossroads Cancer Center James L. Wade Ph: 217-876-4740 Email: kcheek@dmhhs.org Eureka Illinois CancerCare - Eureka Galesburg Galesburg Clinic, PC Medical and Surgical Specialists, LLC Highland Park Hematology Oncology Associates of Illinois-Highland Park Timothy M. Kuzel Ph: 312-695-1301 Email: cancer@northwestern.edu Page 7 of 17
Kankakee Provena St. Mary's Regional Cancer Center - Kankakee Timothy M. Kuzel Ph: 312-695-1301 Email: cancer@northwestern.edu Kewanee Illinois CancerCare - Kewanee Clinic Libertyville North Shore Oncology and Hematology Associates, Limited - Libertyville Timothy M. Kuzel Ph: 312-695-1301 Email: cancer@northwestern.edu Macomb Illinois CancerCare - Macomb Niles Cancer Care and Hematology Specialists of Chicagoland - Niles Timothy M. Kuzel Ph: 312-695-1301 Email: cancer@northwestern.edu Ottawa Illinois CancerCare - Ottawa Pekin Cancer Treatment Center at Pekin Hospital Illinois CancerCare - Pekin Peoria Illinois CancerCare - Peoria Page 8 of 17
Methodist Medical Center of Illinois OSF St. Francis Medical Center Peru Illinois CancerCare - Princeton Princeton Illinois CancerCare - Princeton Skokie Hematology Oncology Associates - Skokie Timothy M. Kuzel Ph: 312-695-1301 Email: cancer@northwestern.edu Springfield Regional Cancer Center at Memorial Medical Center James L. Wade Ph: 217-876-4740 Email: kcheek@dmhhs.org Indiana Elkhart Michiana Hematology-Oncology, PC - Elkhart Mishawaka Michiana Hematology-Oncology, PC - Mishawaka Saint Joseph's Medical Center Plymouth Michiana Hematology Oncology PC - Plymouth Page 9 of 17
South Bend CCOP - Northern Indiana CR Consortium Memorial Hospital of South Bend Michiana Hematology-Oncology, PC - South Bend Westville Michiana Hematology Oncology-PC Westville Iowa Ames McFarland Clinic, PC Joseph James Merchant Ph: 515-239-2621 William R. Bliss Cancer Center at Mary Greeley Medical Center Joseph James Merchant Ph: 515-239-2621 Boone McFarland Clinic PC-Boone Fort Dodge Joseph James Merchant Ph: 515-239-2621 Trinity Regional Medical Center Jefferson Joseph James Merchant Ph: 515-239-2621 McFarland Clinic PC-Jefferson Joseph James Merchant Ph: 515-239-2621 Marshalltown McFarland Clinic PC-Marshalltown Page 10 of 17
Sioux City Joseph James Merchant Ph: 515-239-2621 Siouxland Hematology-Oncology Associates, LLP Donald Bruce Wender Ph: 712-252-0088 Kansas Chanute Cancer Center of Kansas, PA - Chanute Dodge City Cancer Center of Kansas, PA - Dodge City El Dorado Cancer Center of Kansas, PA - El Dorado Fort Scott Cancer Center of Kansas - Fort Scott Independence Cancer Center of Kansas-Independence Kingman Cancer Center of Kansas, PA - Kingman Lawrence Lawrence Memorial Hospital Liberal Page 11 of 17
Cancer Center of Kansas, PA - Liberal Newton Cancer Center of Kansas, PA - Newton Parsons Cancer Center of Kansas, PA - Parsons Pratt Cancer Center of Kansas, PA - Pratt Salina Cancer Center of Kansas, PA - Salina Wellington Cancer Center of Kansas, PA - Wellington Wichita Associates in Women's Health, PA - North Hillside 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 Winfield Page 12 of 17
Cancer Center of Kansas, PA - Winfield Maryland Baltimore Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Jenny J Kim Ph: 410-955-8804 Email: jhcccro@jhmi.edu Michigan Ann Arbor Saint Joseph Mercy Cancer Center Dearborn Oakwood Cancer Center at Oakwood Hospital and Medical Center Detroit Van Elslander Cancer Center at St. John Hospital and Medical Center Flint Genesys Hurley Cancer Institute Hurley Medical Center Jackson Gayle M. Jacob Cancer Center at Allegiance Health Lansing Sparrow Regional Cancer Center Page 13 of 17
Livonia St. Mary Mercy Hospital Niles Lakeland Hospital - Niles Pontiac St. Joseph Mercy Oakland Port Huron Mercy Regional Cancer Center at Mercy Hospital Saginaw Seton Cancer Institute at Saint Mary's - Saginaw Saint Joseph Lakeside Cancer Specialists, PLLC St. Joseph Lakeland Regional Cancer Care Center - St. Joseph Warren St. John Macomb Hospital Missouri Cape Girardeau Saint Francis Medical Center Page 14 of 17
James L. Wade Ph: 217-876-4740 Email: kcheek@dmhhs.org Ohio Akron Summa Center for Cancer Care at Akron City Hospital Lima Jennifer E Payne Ph: 330-375-6101 St. Rita's Medical Center Henry Gerad Ph: 419-226-9617 Pennsylvania Danville Geisinger Cancer Institute at Geisinger Health Hazleton Rajiv Panikkar Ph: 570-271-5251 Geisinger Hazleton Cancer Center Lewisburg Rajiv Panikkar Ph: 570-271-5251 Geisinger Medical Oncology at Evangelical Community Hospital Lewistown Rajiv Panikkar Ph: 570-271-5251 Lewistown Hospital Philadelphia Rajiv Panikkar Ph: 570-271-5251 Abramson Cancer Center of the University of Pennsylvania Pittsburgh Naomi S. Balzer-Haas Ph: 800-474-9892 UPMC Cancer Centers Leonard Joseph Appleman Ph: 412-647-8073 Page 15 of 17
Pottsville Geisinger Medical Oncology-Pottsville Rajiv Panikkar Ph: 570-271-5251 State College Geisinger Medical Group - Scenery Park Rajiv Panikkar Ph: 570-271-5251 Wilkes-Barre Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Rajiv Panikkar Ph: 570-271-5251 West Virginia Morgantown Mary Babb Randolph Cancer Center at West Virginia University Hospitals Thomas F. Hogan Ph: 304-293-2745 Email: sfilburn@hsc.wvu.edu Wisconsin Appleton Fox Valley Hematology and Oncology - East Grant Street Avi Bar-Lev Ph: 920-749-1171 Johnson Creek UW Cancer Center Johnson Creek Madison Glenn Liu Ph: 877-405-6866 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Milwaukee Glenn Liu Ph: 877-405-6866 Froedtert Hospital and Medical College of Wisconsin Kathryn A Bylow Ph: 414-805-4380 Page 16 of 17
Link to the current ClinicalTrials.gov record. NLM Identifer NCT01164228 ClinicalTrials.gov processed this data on July 26, 2014 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov. Page 17 of 17