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Pazopanib Hydrochloride in Treating Patients With Metastatic Urethral Cancer or Bladder Cancer That Has Relapsed or Not Responded to Treatment

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ClinicalTrials.gov Identifier: NCT01031875
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : August 12, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE December 13, 2009
First Posted Date  ICMJE December 15, 2009
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE December 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2009)
Response rate (complete and partial response) according to RECIST 1.1 criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2009)
  • Safety and tolerability, in terms of incidence, nature, and severity of treatment-related adverse events according to CTCAE v4.0
  • Progression-free survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pazopanib Hydrochloride in Treating Patients With Metastatic Urethral Cancer or Bladder Cancer That Has Relapsed or Not Responded to Treatment
Official Title  ICMJE Phase 2 Study With the Multi-Targeted Tyrosine-Kinase Inhibitor Pazopanib (GW786034) for Patients With Relapsed or Refractory Urothelial Cancer
Brief Summary

RATIONALE: Pazopanib hydrochloride 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 how well pazopanib hydrochloride works in treating patients with or metastatic urothelial cancer or bladder cancer that has relapsed or not responded to treatment.

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the activity of daily oral doses of pazopanib hydrochloride monotherapy in patients with relapsed/refractory metastatic urothelial carcinoma or transitional cell tumors.

Secondary

  • To evaluate the safety and tolerability of pazopanib hydrochloride monotherapy in a population of chemotherapy pretreated patients.
  • To assess progression-free survival of these patients.

Tertiary

  • To evaluate the ability of whole-body 18FDG-PET to image metastases and monitor tumor response and to determine the rate of concordance with CT imaging and RECIST response criteria.
  • To evaluate the relationship existing between tumor response measured by 18FDG-PET and progression-free survival.

OUTLINE: This is a multicenter study.

Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo whole-body 18FDG-PET at baseline and periodically.

After completion of study treatment, patients are followed for 2 years.

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
  • Urethral Cancer
Intervention  ICMJE
  • Drug: pazopanib hydrochloride
  • Radiation: fludeoxyglucose F 18
Study Arms  ICMJE Not Provided
Publications * Necchi A, Mariani L, Zaffaroni N, Schwartz LH, Giannatempo P, Crippa F, Morosi C, Lanocita R, Sava T, Ortega C, Messina C, Sacco C, Pennati M, Daidone MG, Nicolai N, De Braud F, Gianni AM, Salvioni R. Pazopanib in advanced and platinum-resistant urothelial cancer: an open-label, single group, phase 2 trial. Lancet Oncol. 2012 Aug;13(8):810-6. doi: 10.1016/S1470-2045(12)70294-2. Epub 2012 Jul 20.

*   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: December 13, 2009)
41
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of transitional cell tumors of the bladder or the urothelium

    • Metastatic disease
    • Relapsed or refractory disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan
  • Must have failed ≥ 1 cisplatin-based conventional chemotherapy regimen for metastatic disease (neoadjuvant/adjuvant therapy excluded)
  • No history or clinical evidence of CNS metastases or leptomeningeal carcinomatosis, except for individuals who were previously treated for CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for the past 6 months

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count ≥ 1,000/μL
  • Platelet count ≥ 75,000/μL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
  • Alkaline phosphatase ≤ 4 x ULN
  • Serum creatinine ≤ 1.5 mg/dL
  • PT-INR/PTT < 1.5 x ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after completion of study therapy
  • Able to swallow oral medication
  • None of the following cardiovascular conditions within the past 6 months:

    • Cardiac angioplasty or stenting
    • Myocardial infarction
    • Unstable angina
    • Symptomatic peripheral vascular disease
    • NYHA class III or IV congestive heart failure
    • Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
    • Uncontrolled hypertension
  • No history of HIV infection or active chronic hepatitis B or C
  • No active clinically serious infections > grade 2 NCI-CTC version 4.0
  • No seizure disorder requiring medication (e.g., steroids or anti-epileptics)
  • No history of any of the following conditions within the past 6 months:

    • Cerebrovascular accident
    • Pulmonary embolism
    • Untreated deep venous thrombosis
  • No evidence or history of bleeding diathesis
  • No known endobronchial lesions or involvement of large pulmonary vessels by tumor
  • No hemoptysis within the past 6 weeks
  • No gastrointestinal abnormalities that may increase the risk of GI bleeding or affect the absorption of investigational study drug
  • No other cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, or any cancer curatively treated > 5 years prior to study entry
  • No substance abuse, medical, psychological, or social conditions that may interfere with the study participation or evaluation of the study results
  • No concurrent unstable condition that could jeopardize patient safety and their compliance in the study
  • No non-healing wound, fracture, or ulcer within the past 28 days
  • No major trauma within the past 28 days
  • No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib hydrochloride

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • At least 14 days since prior radiotherapy, except palliative radiotherapy
  • At least 14 days since tumor embolization
  • At least 14 days or 5 half-lives (whichever is longer) of a drug since prior chemotherapy, immunotherapy, biologic therapy, investigational therapy, or hormonal therapy
  • At least 3 weeks since prior biologic response modifiers (e.g., G-CSF)

    • G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity (e.g., febrile neutropenia) when clinically indicated or at the discretion of the investigator, however they may not be used to avoid a required dose reduction
    • Chronic erythropoietin allowed provided no dose adjustment is undertaken within 2 months prior to the study or during the study
  • No prior pazopanib hydrochloride
  • No coronary artery by-pass graft surgery within the past 6 months
  • No major surgery within the past 28 days
  • Concurrent coumadin or heparin for therapeutic anticoagulation allowed provided that no prior evidence of underlying abnormality in PT-INR/PTT parameters exist
  • Not concurrently undergoing renal dialysis
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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01031875
Other Study ID Numbers  ICMJE ITA-MIL-IRCCS-INT-70/09
CDR0000661071 ( Registry Identifier: PDQ (Physician Data Query) )
EUDRACT-2009-017093-20
EU-20990
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 Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Roberto Salvioni, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigator: Nicola Nicolai, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigator: Andrea Necchi, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
PRS Account National Cancer Institute (NCI)
Verification Date September 2012

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