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

Primary Purpose

Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
sunitinib malate
Sponsored by
Institut Curie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Rene Huguenin
  • Hopital Foch

Outcomes

Primary Outcome Measures

Objective response as assessed by RECIST criteria

Secondary Outcome Measures

Progression-free survival
Overall survival
Time to response and duration of response
Safety
Quality of life

Full Information

First Posted
November 14, 2008
Last Updated
May 14, 2011
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT00792025
Brief Title
Sunitinib as Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Transitional Cell Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Curie

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Primary Outcome Measure Information:
Title
Objective response as assessed by RECIST criteria
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Overall survival
Title
Time to response and duration of response
Title
Safety
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Theodore, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

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

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