Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

NCT01118351

Last updated date
Study Location
CCF-Fairview Hospital
Cleveland, Ohio, 44111, 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.
Recurrent Bladder Cancer, Transitional Cell Carcinoma of the Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Recurrent Bladder Cancer, Transitional Cell Carcinoma of the BladderSunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer
NCT01118351
  1. Cleveland, Ohio
  2. Cleveland, Ohio
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer
Official Title  ICMJE Phase II Single Arm, Open Label, Single Institution Study of Continuous Sunitinib (Sutent) in Patients With High-Risk (BCG-Refractory) Superficial Transitional Cell Carcinoma (TCC) of the Bladder
Brief 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.

PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with recurrent transitional cell bladder cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the clinical efficacy of oral sunitinib (Sutent) given continuously for a maximum of 12 weeks, with respect to complete response rates at 12 months after completion of treatment in patients with high-risk superficial bladder cancer who have failed previous intravesical BCG.

SECONDARY OBJECTIVES:

I. To assess the impact of sunitinib treatment in recurrence-free survival, progression-free survival, and overall survival in patients with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.

II. To evaluate the safety and tolerability of sunitinib (Sutent) administered in patients with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.

TERTIARY OBJECTIVES:

I. To assess pre-treatment tissue baseline angiogenic markers and to evaluate the magnitude of the difference among these variables with post-treatment tumor tissue after treatment with sunitinib (Sutent).

II. To evaluate the effects of Sunitinib (Sutent) on immunosuppressive regulatory T cells (Tregs).

III. To determine the presence of circulating tumor cells in superficial BCG-refractory TCC patients.

OUTLINE:

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

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
  • Recurrent Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
Intervention  ICMJE
  • Drug: sunitinib malate
    Given orally
    Other Names:
    • SU011248
    • SU11248
    • sunitinib
    • Sutent
  • Other: immunohistochemistry staining method
    Correlative studies
    Other Name: immunohistochemistry
  • Other: TdT-mediated dUTP nick end labeling assay
    Correlative studies
    Other Name: TUNEL assay
  • Other: light microscopy
    Correlative studies
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: sunitinib malate
  • Other: immunohistochemistry staining method
  • Other: TdT-mediated dUTP nick end labeling assay
  • Other: light microscopy
  • Other: laboratory biomarker analysis
Publications * Zahoor H, Mir MC, Barata PC, Stephenson AJ, Campbell SC, Fergany A, Dreicer R, Garcia JA. Phase II trial of continuous treatment with sunitinib in patients with high-risk (BCG-refractory) non-muscle invasive bladder cancer. Invest New Drugs. 2019 Dec;37(6):1231-1238. doi: 10.1007/s10637-018-00716-w. Epub 2019 Jun 24.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 4, 2012)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2010)
36
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion

  • Patients must have clinically and histologically proven, recurrent superficial transitional cell carcinoma of the bladder after treatment with BCG therapy
  • Patients could have received previous any INTRAVESICAL therapy including BCG and/or IFN and/or chemotherapy up to 3 years prior to registration
  • Patients biopsy specimen should be available for review
  • ECOG PS 0-1 (Karnofsky greater than 70%)
  • Absolute neutrophil count >= 1,000/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 8.5 g/dl
  • Total bilirubin =< 1.5 X institutional upper limit of normal
  • AST(SGOT)/ALT(SGPT) =< 3.5 X institutional upper limit of normal
  • Alkaline phosphatase =< 2.5 ULN ( =< 10 x ULN in presence of bone metastasis)
  • Serum calcium of =< 12 mg/dl
  • Creatinine =< 1.5 X institutional upper limit of normal
  • INR =< 1.5, except for subjects receiving warfarin therapy
  • Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of Sunitinib (Sutent) will be determined following review of their case by the Principal Investigator
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; sexually active patients must continue to use contraception for three months after completion of study therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines

Exclusion

  • Prior systemic chemotherapy for bladder cancer; all other systemic chemotherapy must have been completed at least 3 years prior to enrollment
  • Prior treatment with any other anti-angiogenic therapy (including immunomodulatory agents such as thalidomide and lenalidomide, and anti-VEGF therapy with agents such as bevacizumab (Bevacizumab Avastin, Sunitinib (Sutent) and Sorafenib (Nexavar)
  • Prior major surgery (not TURBT/Cystoscopy), radiation therapy, or systemic therapy within 4 weeks of starting the study treatment
  • NCI CTCAE grade 3 hemorrhage within 4 weeks of starting study treatment
  • 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
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade >= 2, or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females (Atrial Fibrillation is allowed provided patients are rated controlled)
  • Hypertension that cannot be controlled by medications
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) - related illness or infectious hepatitis type A, B or C
  • Disease-free of prior malignancies for >= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment
  • Pregnancy or breastfeeding (Female patients must be surgically sterile or postmenopausal, or must agree to use effective contraception during the period of therapy; all female patients with reproductive potential must have a negative pregnancy test [serum or urine] prior to enrollment)
  • Male patients must be surgically sterile 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 principal investigator or a designated associate)
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 NCT01118351
Other Study ID Numbers  ICMJE CASE3808
NCI-2010-01137 ( Other Identifier: NCI/CTRP )
CASE 3808-CC530 ( Other Identifier: Cancer Center IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Jorge Garcia, MDCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP