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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)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Drug: sunitinib malate Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2008
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Objective response as assessed by RECIST criteria

Secondary Outcome Measures :
  1. Progression-free survival
  2. Overall survival
  3. Time to response and duration of response
  4. Safety
  5. Quality of life

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792025


Locations
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France
Centre Rene Huguenin
Saint Cloud, France, 92211
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: Christine Theodore, MD Hopital Foch
More Information
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ClinicalTrials.gov Identifier: NCT00792025    
Other Study ID Numbers: CDR0000618219
FRE-CRH-06-374-M
FRE CRH-VESSU
INCA-RECF0845
EUDRACT-2008-001004-22
PFIZER-FRE-CRH-06/374/M
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
stage III bladder cancer
 stage IV bladder cancer
transitional cell carcinoma of the bladder
recurrent bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Kidney Diseases
Ureteral Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action