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

NCT00792025 | Completed Phase 2

• 6 other identifiers: CDR0000618219FRE-CRH-06-374-MFRE CRH-VESSUINCA-RECF0845EUDRACT-2008-001004-22PFIZER-FRE-CRH-06/374/M
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Objective response as assessed by RECIST criteria

Secondary Outcomes (5)

• Progression-free survival

• Overall survival

• Time to response and duration of response

• Safety

• Quality of life

Interventions

sunitinib malate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (2)

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Hopital Foch

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Christine Theodore, MD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 17, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2011
• Last Updated: May 17, 2011

Record last verified: 2009-07

Locations

FR (2)