Gemzar, Cisp, Sunitinib Urothelial Ca

NCT00821327

Last updated date
Study Location
Arizona Oncology Associates
Tucson, Arizona, 85704, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urothelial Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Urothelial CancerGemzar, Cisp, Sunitinib Urothelial Ca
NCT00821327
  1. Tucson, Arizona
  2. Miami, Florida
  3. New Port Richey, Florida
  4. Ocoee, Florida
  5. Chicago, Illinois
  6. Niles, Illinois
  7. Indianapolis, Indiana
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  12. Las Vegas, Nevada
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  43. Norfolk, Virginia
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  45. Burien, Washington
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Urothelial CancerA Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
NCT02603432
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  6. New Haven, Connecticut
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  8. Atlanta, Georgia
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  27. Lismore, New South Wales
  28. Macquarie University, New South Wales
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  33. Tweed Heads, New South Wales
  34. Auchenflower, Queensland
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  370. Porto Alegre, RS
  371. Taipei,
  372. Sao Paulo, SP
  373. Barcelona,
  374. Moscow,
  375. Arnhem,
  376. Madrid,
  377. Kiryat Hadassah, Jerusalem
  378. Salvador, BA
  379. Caba,
  380. Kagoshima,
  381. Barcelona,
  382. Lisboa,
  383. Pardubice,
  384. Itabashi-ku, Tokyo
  385. Nordbyhagen,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
 (submitted: May 20, 2014)
36
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)
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:

  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

Exclusion Criteria:

  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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Guru Sonpavde, MDUS Oncology
Principal Investigator:Thomas E Hutson, DOUS Oncology
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