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Sunitinib as Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Transitional Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00792025
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 14, 2008
First Posted Date  ICMJE November 17, 2008
Last Update Posted Date May 17, 2011
Study Start Date  ICMJE December 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
Objective response as assessed by RECIST criteria
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
Tumor response rate by RECIST criteria
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
  • Progression-free survival
  • Overall survival
  • Time to response and duration of response
  • Safety
  • Quality of life
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunitinib as Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Transitional Cell Cancer
Official Title  ICMJE A Multicentre Phase II Trial to Determine the Efficacy of the Anti-Tyrosine Kinase Sunitinib (Sutent®) as Second Line Therapy in Patients With Transitional Cell Carcinoma (TCC) of the Urothelium Which Failed or Progressed After First Line Chemotherapy for Advanced or Metastatic Disease
Brief Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying sunitinib to see how well it works as second-line therapy in treating patients with locally advanced or metastatic transitional cell cancer.

Detailed Description

OBJECTIVES:

Primary

  • To determine the objective tumor response rate according to RECIST criteria in patients with locally advanced or metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate who failed or progressed after first-line chemotherapy .

Secondary

  • To determine the safety of this drug.
  • To determine the time to response and duration of response.
  • To determine the progression-free survival and overall survival of these patients.
  • To evaluate the quality of life of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks for 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
Intervention  ICMJE Drug: sunitinib malate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: November 14, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell cancer of the urothelium

    • Advanced or metastatic disease
    • Disease failed or progressed after first-line chemotherapy
  • At least 1 non-irradiated measurable lesion assessed by CT scan or MRI according to RECIST
  • No progressive brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in presence of liver metastases)
  • Creatinine clearance ≥ 40 mL/min
  • PTT and INR ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study treatment
  • No uncontrolled high BP, defined as > 150/100 mm Hg despite treatment
  • No diagnosis of a second malignancy within the past 5 years, except for basal cell or squamous cell carcinoma of the skin, incidental PT2 prostate cancer found on radical cystoprostatectomy material, or carcinoma in situ of the cervix, that has been adequately treated with no evidence of recurrence in the past 12 months
  • None of the following within the past 12 months:

    • Myocardial infarction
    • Severe/unstable angina pectoris
    • Coronary artery bypass graft
    • Symptomatic congestive heart failure
    • Cerebrovascular accident
    • Transient ischemic attack
    • Pulmonary embolism
  • At least 6 months since deep vein thrombosis
  • No NCI CTCAE grade 3 hemorrhage within the past 4 weeks
  • No pre-existing neuropathy ≥ NCI CTCAE grade 2
  • No history of interstitial pneumonitis or pulmonary fibrosis
  • No ongoing cardiac arrhythmias ≥ NCI CTCAE grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval (> 450 msec for males or > 470 msec for females)
  • No ongoing active infection
  • No patients deprived of liberty or who are under supervision (including a trusteeship)
  • No psychological, familial, sociological, or geographic condition potentially hampering compliance with study treatment and follow-up
  • Patients must be affiliated to a social security system

PRIOR CONCURRENT THERAPY:

  • Prior platinum-based therapy allowed
  • No prior sunitinib malate
  • No prior radiotherapy to ≥ 25% of marrow producing area
  • Prior neoadjuvant or adjuvant chemotherapy allowed
  • More than 2 weeks since prior and no concurrent oral anticoagulant agents at therapeutic doses

    • Low molecular weight heparin allowed
  • At least 30 days since prior chemotherapy or radiotherapy and recovered
  • No other concurrent anticancer treatment, including experimental agents, or participation in another investigational trial
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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00792025
Other Study ID Numbers  ICMJE CDR0000618219
FRE-CRH-06-374-M
FRE CRH-VESSU
INCA-RECF0845
EUDRACT-2008-001004-22
PFIZER-FRE-CRH-06/374/M
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Institut Curie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christine Theodore, MD Hopital Foch
PRS Account National Cancer Institute (NCI)
Verification Date July 2009

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