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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00792025
Enrollment
80
Registered
2008-11-17
Start date
2008-12-31
Completion date
Unknown
Last updated
2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGsunitinib malate

Sponsors

Institut Curie
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Objective response as assessed by RECIST criteria

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026