Gemzar, Cisp, Sunitinib Urothelial Ca
Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma
2 other identifiers
interventional
36
1 country
48
Brief Summary
The primary objective of this nonrandomized Phase II study is to evaluate the objective response rate (ORR, CR+PR) in patients with advanced/metastatic UC treated with the combination of gemcitabine, cisplatin, and sunitinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2008
Typical duration for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 9, 2009
CompletedFirst Posted
Study publicly available on registry
January 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
March 2, 2016
CompletedOctober 25, 2016
September 1, 2016
4 years
January 9, 2009
January 12, 2016
September 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
2 years
Secondary Outcomes (2)
Progression-free Survival
2 years
Ovarall Survival (OS)
2 years
Study Arms (1)
Study Arm
EXPERIMENTALGemcitabine, Cisplatin, Sunitinib
Interventions
Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle. 2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy. 3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
Eligibility Criteria
You may qualify if:
- Has histological documentation of diagnosis of transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis (histology may be mixed, but still requires a component of TCC; measurable disease only)
- Has unresectable or metastatic disease
- Has a Karnofsky Performance Status greater than or equal 60 percent
- Is 18 years of age or older
- Has laboratory values as defined by the protocol
- Has resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE (v3.0) Grade less than or equal to 1
- Has normal cardiac function as evidenced by a LVEF greater than or equal to 50 percent, as determined by multiple gated acquisition (MUGA) scan or an echocardiogram (ECHO). The same method must be used throughout the study to evaluate LVEF.
- Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential \[not surgically sterilized and between menarche and 1 year postmenopausal\])
- Is not currently breastfeeding
- If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.
- Has signed a Patient Informed Consent Form, Has signed a Patient Authorization Form
You may not qualify if:
- Has had prior treatment with systemic chemotherapy (prior intravesical therapy is permitted)
- Has had major surgery or radiation therapy within 4 weeks of starting the study treatment
- Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the study treatment
- Has a history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
- Has had any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
- Has ongoing cardiac dysrhythmias of NCI CTCAE (Version 3.0) Grade 2
- Has prolonged QTc interval on baseline EKG
- Has uncontrolled hypertension (grater than 150/100 mm Hg despite optimal medical therapy)
- Has pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Has known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
- Is receiving concomitant use of any other investigational drugs or has received such drug within 28 days prior to registration
- Is receiving concurrent treatment on another clinical trial, including supportive care
- Has ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for thromboembolic prophylaxis allowed). Patients on warfarin (greater than 2mg) for thrombosis must be switched to low molecular weight heparin (ie, Lovenox), prior to registration for protocol therapy.
- Is currently taking drugs having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide) within 7 days prior to Day 1 of Cycle 1 (dosing) (and throughout study)
- Is currently on CYP3A4 inhibitors (see Section 5) within 7 days prior to Day 1 of Cycle 1 (dosing), with the exception of amiodarone, which should be discontinued within 6 months prior to Day 1 of Cycle 1 (dosing)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Oncology Researchlead
- Pfizercollaborator
Study Sites (48)
Arizona Oncology Associates
Tucson, Arizona, 85704, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Florida Cancer Institute - New Hope
New Port Richey, Florida, 34655, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, 60611, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Alliance Hematology Oncology PA.
Westminster, Maryland, 21157, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Arch Medical Services, Inc.
Saint Louiis, Missouri, 63141, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, 07962, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27607, United States
Willamette Valley Cancer Center
Springfield, Oregon, 97477, United States
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, 18704, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
Texas Cancer Center - Abilene
Abilene, Texas, 79606, United States
Texas Oncology, P.A. -Amarillo
Amarillo, Texas, 79106, United States
Texas Cancer Center
Arlington, Texas, 76014, United States
Texas Oncology - Round Rock Cancer Center
Austin, Texas, 78731, United States
Mamie McFaddin Ward Cancer Center, Texas Oncology
Beaumont, Texas, 77702, United States
Texas Oncology, P.A. - Bedford
Bedford, Texas, 76022, United States
Texas Oncology
Dallas, Texas, 75230, United States
Texas Oncology/Methodist Charlton Cancer Ctr.
Dallas, Texas, 75237, United States
Texas Oncology, P.A.
Dallas, Texas, 75246, United States
Texas Cancer Center
Denton, Texas, 76210, United States
El Paso Cancer Treatment Center - East
El Paso, Texas, 79915, United States
Texas Oncology
Fort Worth, Texas, 76104, United States
Texas Oncology
Garland, Texas, 75042-5788, United States
Longview Cancer Center
Longview, Texas, 75601, United States
South Texas Cancer Center
McAllen, Texas, 78503, United States
Texas Oncology, PA, Allison Cancer Center
Midland, Texas, 79701, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78217, United States
Cancer Care Centers of South Texas-HOAST
San Antonio, Texas, 78229, United States
Texas Cancer Center - Sherman
Sherman, Texas, 75090, United States
Texas Oncology Cancer Center - Sugar Land
Sugar Land, Texas, 77479, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Texas Oncology Cancer Care and Research Center
Waco, Texas, 76712, United States
Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, 24153, United States
Highline Medical Oncology
Burien, Washington, 98166, United States
Pudget Sound Cancer Center
Edmonds, Washington, 98026, United States
Cancer Care Northwest
Spokane, Washington, 99202, United States
Northwest Cancer Specialists, PC
Vancouver, Washington, 98684, United States
Related Publications (1)
Galsky MD, Hahn NM, Powles T, Hellerstedt BA, Lerner SP, Gardner TA, Yu M, O'Rourke M, Vogelzang NJ, Kocs D, McKenney SA, Melnyk AM Jr, Hutson TE, Rauch M, Wang Y, Asmar L, Sonpavde G. Gemcitabine, Cisplatin, and sunitinib for metastatic urothelial carcinoma and as preoperative therapy for muscle-invasive bladder cancer. Clin Genitourin Cancer. 2013 Jun;11(2):175-81. doi: 10.1016/j.clgc.2012.10.001. Epub 2012 Dec 8.
PMID: 23228446DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Matthew D. Galsky
- Organization
- US Oncology Research, McKesson Specialty Health
Study Officials
- PRINCIPAL INVESTIGATOR
Guru Sonpavde, MD
US Oncology
- PRINCIPAL INVESTIGATOR
Thomas E Hutson, DO
US Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2009
First Posted
January 13, 2009
Study Start
August 1, 2008
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
October 25, 2016
Results First Posted
March 2, 2016
Record last verified: 2016-09