Sunitinib as Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Transitional Cell Cancer
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ClinicalTrials.gov Identifier: NCT00792025 |
Recruitment Status :
Completed
First Posted : November 17, 2008
Last Update Posted : May 17, 2011
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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 |
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 Type : | Interventional (Clinical Trial) |
Estimated 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 : | December 2008 |
Actual Primary Completion Date : | May 2011 |

- Objective response as assessed by RECIST criteria
- Progression-free survival
- Overall survival
- Time to response and duration of response
- Safety
- Quality of life

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792025
France | |
Centre Rene Huguenin | |
Saint Cloud, France, 92211 | |
Hopital Foch | |
Suresnes, France, 92151 |
Principal Investigator: | Christine Theodore, MD | Hopital Foch |
ClinicalTrials.gov Identifier: | NCT00792025 |
Other Study ID Numbers: |
CDR0000618219 FRE-CRH-06-374-M FRE CRH-VESSU INCA-RECF0845 EUDRACT-2008-001004-22 PFIZER-FRE-CRH-06/374/M |
First Posted: | November 17, 2008 Key Record Dates |
Last Update Posted: | May 17, 2011 |
Last Verified: | July 2009 |
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 |
Urinary Bladder Neoplasms Carcinoma, Transitional Cell Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Kidney Diseases Ureteral Diseases Sunitinib Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |