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

Sponsor

Institut Curie (Other)

Overall Status

Completed

CT.gov ID

NCT00792025

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

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.

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

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2008

Actual Primary Completion Date :

May 1, 2011

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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