ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. 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)
2. Has unresectable or metastatic disease
3. Has a Karnofsky Performance Status greater than or equal 60 percent
4. Is 18 years of age or older
5. Has laboratory values as defined by the protocol
6. 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
7. 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.
8. 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])
9. Is not currently breastfeeding
10. 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.
11. Has signed a Patient Informed Consent Form, Has signed a Patient Authorization Form
1. Has had prior treatment with systemic chemotherapy (prior intravesical therapy is
permitted)
2. Has had major surgery or radiation therapy within 4 weeks of starting the study
treatment
3. Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the
study treatment
4. 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.
5. 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
6. Has ongoing cardiac dysrhythmias of NCI CTCAE (Version 3.0) Grade 2
7. Has prolonged QTc interval on baseline EKG
8. Has uncontrolled hypertension (grater than 150/100 mm Hg despite optimal medical
therapy)
9. Has pre-existing thyroid abnormality with thyroid function that cannot be maintained
in the normal range with medication
10. Has known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness or other active infection
11. Is receiving concomitant use of any other investigational drugs or has received such
drug within 28 days prior to registration
12. Is receiving concurrent treatment on another clinical trial, including supportive care
13. 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.
14. 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)
15. 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)
16. Is currently on CYP3A4 inducers (see Section 5) within 14 days prior to Day 1 of Cycle
1 (dosing)
17. Has been taking herbal or alternative medications within the past 7 days or refuses to
discontinue the use of herbal or alternative therapies within 7 days prior to Day 1 of
Cycle 1 (dosing)
18. Has a serious uncontrolled intercurrent medical or psychiatric illness, including
serious infection
19. Has a history of other malignancy within the last 5 years (except cured basal cell
carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the
diagnosis or assessment of any of the study drugs.
20. Is a pregnant or nursing woman. Patients must be surgically sterile or be
postmenopausal, or must agree to use effective contraception during the period of
therapy. The definition of effective contraception will be based on the judgment of
the Study Investigator or Treating Physician. Male patients must be surgically sterile
or agree to use effective contraception.
Is unable to comply with requirements of study
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Tucson, Arizona
- Miami, Florida
- New Port Richey, Florida
- Ocoee, Florida
- Chicago, Illinois
- Niles, Illinois
- Indianapolis, Indiana
- Westminster, Maryland
- Minneapolis, Minnesota
- Columbia, Missouri
- St. Louiis, Missouri
- Las Vegas, Nevada
- Morristown, New Jersey
- Santa Fe, New Mexico
- Albany, New York
- Raleigh, North Carolina
- Springfield, Oregon
- Kingston, Pennsylvania
- Greenville, South Carolina
- Abilene, Texas
- Amarillo, Texas
- Arlington, Texas
- Austin, Texas
- Beaumont, Texas
- Bedford, Texas
- Dallas, Texas
- Dallas, Texas
- Dallas, Texas
- Denton, Texas
- El Paso, Texas
- Fort Worth, Texas
- Garland, Texas
- Longview, Texas
- McAllen, Texas
- Midland, Texas
- San Antonio, Texas
- San Antonio, Texas
- Sherman, Texas
- Sugar Land, Texas
- Tyler, Texas
- Waco, Texas
- Webster, Texas
- Norfolk, Virginia
- Salem, Virginia
- Burien, Washington
- Edmonds, Washington
- Spokane, Washington
- Vancouver, Washington
- Aurora, Colorado
- Aurora, Colorado
- Aurora, Colorado
- Aurora, Colorado
- Aurora, Colorado
- New Haven, Connecticut
- New Haven, Connecticut
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Boston, Massachusetts
- Minneapolis, Minnesota
- Minneapolis, Minnesota
- Cleveland, Ohio
- Cleveland, Ohio
- Fairfax, Virginia
- Seattle, Washington
- Seattle, Washington
- Seattle, Washington
- Camperdown, New South Wales
- Camperdown, New South Wales
- Concord, New South Wales
- Concord, New South Wales
- Kogarah, New South Wales
- Kogarah, New South Wales
- Lismore, New South Wales
- Macquarie University, New South Wales
- Macquarie University, New South Wales
- St Leonards, New South Wales
- St Leonards, New South Wales
- St Leonards, New South Wales
- Tweed Heads, New South Wales
- Auchenflower, Queensland
- Auchenflower, Queensland
- Birtinya, Queensland
- Birtinya, Queensland
- Chermside, Queensland
- Douglas, Queensland
- Geebung, Queensland
- South Brisbane, Queensland
- South Brisbane, Queensland
- South Brisbane, Queensland
- Southport, Queensland
- Bedford Park, South Australia
- Bedford Park, South Australia
- Kurralta Park, South Australia
- Kurralta park, South Australia
- Kurralta Park, South Australia
- Kurralta Park, South Australia
- Woodville South, South Australia
- Woodville South, South Australia
- Ballarat, Victoria
- Box Hill, Victoria
- Box Hill, Victoria
- Clayton, Victoria
- Wendouree, Victoria
- Wendouree, Victoria
- West Melbourne, Victoria
- Murdoch, Western Australia
- Murdoch, Western Australia
- Angers Cedex 02,
- Angers,
- Bayonne,
- Bayonne,
- BESANCON cedex,
- Besançon,
- CRÉTEIL Cedex,
- Hyères,
- Le Mans,
- Lille cedex,
- Lille,
- Lyon cedex 8,
- LYON cedex 8,
- Marseille cedex 5,
- Marseille Cedex 9,
- Marseille,
- Marseille,
- Marseille,
- Nimes Cedex 9,
- Nimes Cedex 9,
- Nimes,
- PARIS cedex 13,
- Paris,
- Rennes Cedex,
- Rouen,
- Saint Herblain cedex,
- Strasbourg,
- Strasbourg,
- Suresnes,
- Suresnes,
- Villejuif cedex,
- Villejuif,
- Candiolo, (torino)
- Torrette, Ancona
- Meldola, Forli-cesena
- Meldola, Forll-cesena
- Rozzano, Milan
- Rozzano, Milan
- Faenza, Ravenna
- Lugo, Ravenna
- Candiolo, Torino
- Arezzo, Toscana
- Arezzo,
- Bologna,
- Bologna,
- Genova,
- Genova,
- Milan,
- Milan,
- Milan,
- Milan,
- Napoli,
- Napoli,
- Novara,
- Novara,
- Pisa,
- Pisa,
- Rome,
- Rome,
- Terni,
- Terni,
- Headington, Oxford
- Bath,
- London,
- London,
- London,
- London,
- Oxford, Oxfordshire,
- Oxford,
- Ube, Yamaguchi
- Stockholm,
- St. Petersburg,
- Kyoto,
- Moscow,
- Seoul,
- Wilrijk,
- Praha 8,
- St. Petersburg,
- Taichung,
- San Sebastian de los Reyes, Madrid
- Madrid,
- Madrid,
- Cordoba,
- Brampton, Ontario
- Maastricht,
- Tel-Hashomer, Ramat - GAN
- Pamplona, Navarra
- St. Petersburg,
- Yaroslavl,
- Porto,
- Haifa,
- Omsk,
- Madrid,
- Taichung,
- Ijuí, RS
- Vigo, Galicia
- Badajoz,
- Petach Tikva,
- Brno,
- Warszawa, Masovian
- Kumamoto,
- Budapest,
- Aviano (PN),
- Ufa, Bashkortostan Republic
- Herlev,
- Lublin,
- Koto-ku, Tokyo
- Goyang-si, Gyeonggi-do
- Taoyuan,
- Nijmegen,
- Christchurch,
- Seongnam-si, Gyeonggido
- Pushkin, Saint Petersburg
- Athens,
- Goyang-si, Gyeonggi-do
- St. Petersburg,
- Aarhus N,
- Porto,
- Grafton, Auckland
- Matsuyama, Ehime
- Seoul,
- São Paulo, SP
- Hamilton,
- Osaka,
- Leon, Guanajuato
- Barretos, SP
- Taipei,
- Bruxelles,
- Sant Joan d'Alacant, Alicante
- New Delhi, Delhi
- Mexico, Ciudad DE Mexico
- Sabadell, Barcelona
- Stavanger,
- Rio de Janeiro, RJ
- Gerona,
- San Sebastián de los Reyes, Madrid
- Madrid,
- Porto,
- Madrid,
- Budapest,
- Sevilla,
- St. Petersburg,
- Shinjuku-Ku, Tokyo
- Santiago de Compostela, A Coruña
- Elda, Alicante
- Porto Alegre, RS
- Murdoch, Western Australia
- Porto Alegre, RS
- Barcelona,
- Pune, Maharashtra
- Yamagata,
- Porto Alegre, RIO Grande DO SUL
- Hoofddorp,
- Aviano (PN),
- Ravenna,
- Barcelona,
- La Rioja,
- Toronto, Ontario
- Thessaloniki,
- Brno,
- København Ø,
- Ota, Gunma
- Tainan,
- Aarhus C,
- Seoul,
- Örebro,
- Sapporo,, Hokkaido
- Beer Yaakov,
- Tsukuba, Ibaraki
- Hirosaki, Aomori
- Sao Paulo, SP
- Lisboa,
- Badalona, Barcelona
- Yaroslavl,
- Barretos, SP
- Ballarat, Victoria
- Taipei,
- León, Guanajuato
- Madrid,
- Rio de Janeiro, RJ
- Sao Paulo, SP
- Naples,
- Stockholm,
- Brussels,
- Chiba,
- Pamplona, Navarra
- Belgrade,
- Santiago de Compostela, A Coruña
- Lorenskog,
- Daejeon,
- Nagpur, Maharashtra
- St. Petersburg,
- Taichung,
- East Bentleigh, Victoria
- Morioka, Iwate
- Cuautitlan Izcalli, Estado DE Mexico
- La Rioja,
- Sagamihara, Kanagawa
- Praha 8,
- Coimbra,
- Niigata,
- Hiroshima,
- Brasschaat,
- Valencia,
- Kaposvár,
- Sapporo, Hokkaido
- Grafton, Auckland
- São Paulo, SP
- Taoyuan,
- Rio de Janeiro, RJ
- Oviedo, Asturias
- Haarlem,
- Nagoya, Aichi
- Moscow,
- Fukuoka,
- Stavanger,
- Taichung,
- Örebro,
- Montreal, Quebec
- Sao Jose do Rio Preto, SP
- Ahmedabad, Gujarat
- Barcelona,
- Lorenskog,
- Valencia, Comunidad Valenciana
- Alicante, Comunidad Valenciana
- Barcelona,
- Vigo, Galicia
- São Paulo, SP
- São José do Rio Preto, SP
- l´Hospitalet de LLobregat, Barcelona
- St. Petersburg,
- Ravenna,
- Kaposvár,
- Athens,
- Tokushima,
- Rio de Janeiro, RJ
- Pergamino, Buenos Aires
- Daejeon,
- La Rioja,
- L´Hospitalet de Llobregat, Barcelona
- Ramat - Gan,
- Brno,
- Koshigaya, Saitama
- Gerona,
- Arnhem,
- Gent,
- Fukuoka,
- Manresa, Barcelona
- Barcelona,
- Madrid,
- Nadiad, Gujarat
- Hyderabad, Telangana
- Barcelona,
- Barcelona,
- Liège,
- Nijmegen,
- Madrid,
- Brasschaat,
- Nis,
- East Bentleigh, Victoria
- Kolkata, WEST Bengal
- Odense C,
- Seongnam-si, Gyeonggido
- Elche, Comunidad Valenciana
- Vigo, Galicia
- Madrid,
- Seoul,
- A Coruña,
- Athens, Cholargos
- Hong Kong,
- Copenhagen OE,
- St. Petersburg,
- La Rioja,
- Barcelona,
- Madrid,
- Hamamatsu, Shizuoka
- Taipei,
- Horovice,
- Lugo,
- Porte Alegre, RS
- Naples,
- Madrid,
- Porto,
- Patra,
- Coimbra,
- Salvador, BA
- Rio de Janeiro, RJ
- Porto Alegre, RS
- Kobe-city, Hyogo
- Stavanger,
- Barcelona,
- Cordoba,
- Horovice,
- Moscow,
- Aalborg,
- Aarhus N,
- Montreal, Quebec
- Seoul,
- Delhi,
- Yokohama, Kanagawa
- Kortrijk,
- Hidaka, Saitama
- Tainan,
- Porto Alegre, RS
- Odense,
- Osakasayama, Osaka
- Craiova,
- St. Petersburg,
- Porto Alegre, RS
- Taipei,
- Sao Paulo, SP
- Barcelona,
- Moscow,
- Arnhem,
- Madrid,
- Kiryat Hadassah, Jerusalem
- Salvador, BA
- Caba,
- Kagoshima,
- Barcelona,
- Lisboa,
- Pardubice,
- Itabashi-ku, Tokyo
- Nordbyhagen,
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | Gemzar, Cisp, Sunitinib Urothelial Ca | ||||||
Official Title ICMJE | Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma | ||||||
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. | ||||||
Detailed Description | Given the strong preclinical rationale for targeting angiogenesis in urothelial carcinoma (UC), the evidence supporting co-targeting of VEGFR2 and PDGF, the safety and efficacy of single-agent sunitinib in patients with UC, and preclinical evidence of synergy with the combination of sunitinib and cisplatin, the evaluation of sunitinib in combination with gemcitabine plus cisplatin in previously untreated patients with metastatic UC is warranted. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Urothelial Cancer | ||||||
Intervention ICMJE | Drug: Gemcitabine, Cisplatin, Sunitinib
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. Other Name: Gemzar, Sutent | ||||||
Study Arms ICMJE | Experimental: Study Arm
Gemcitabine, Cisplatin, Sunitinib Intervention: Drug: Gemcitabine, Cisplatin, Sunitinib | ||||||
Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 36 | ||||||
Original Estimated Enrollment ICMJE | 43 | ||||||
Actual Study Completion Date ICMJE | August 2012 | ||||||
Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Is unable to comply with requirements of study | ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00821327 | ||||||
Other Study ID Numbers ICMJE | 06040 WS356467 ( Other Identifier: Pfizer ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | US Oncology Research | ||||||
Study Sponsor ICMJE | US Oncology Research | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
| ||||||
PRS Account | US Oncology Research | ||||||
Verification Date | September 2016 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |