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
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
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
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
Learn more about this trial
Sunitinib as Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Transitional Cell Cancer
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