- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00397488
Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with progressive metastatic transitional cell cancer of the urothelium.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine the response rate in patients with progressive metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate.
- Determine the safety of this regimen in these patients.
Secondary
Determine the time to disease progression in patients treated with this regimen.
- To determine time to tumor progression (TTP) for sunitinib malate on a continuous dosing schedule for treatment of metastatic urothelial carcinoma.
- To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for the continuous daily schedule and to determine potential association with efficacy and safety.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the urothelium, including 1 of the following sites:
- Bladder
- Urethra
- Ureter
- Renal pelvis
Progressive metastatic disease
- Progressive disease defined as new or progressive lesions on cross-sectional imaging
- Progressed despite prior treatment with cytotoxic chemotherapy
- Measurable disease
Previously treated disease, as defined by the following:
- Received treatment with 1-4 cytotoxic agents
Prior therapy must have included ≥ 1 of the following:
- Cisplatin
- Carboplatin
- Paclitaxel
- Docetaxel
- Gemcitabine hydrochloride
- Prior cytotoxic agents in the perioperative or metastatic setting allowed and may have been administered sequentially (e.g., first-line treatment followed by second-line treatment at time of progression) or all as part of a single regimen
- No symptomatic CNS metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL
- Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease is present)
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver function abnormalities are due to underlying malignancy)
- Creatinine ≤ 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
None of the following within the past 6 months:
- Myocardial infarction
- Severe or unstable angina
- Coronary or peripheral artery bypass graft
- Symptomatic congestive heart failure
- Cerebrovascular accident or transient ischemic attack
- Pulmonary embolism
- No ongoing cardiac dysrhythmias ≥ grade 2
- No prolonged QTc interval on baseline ECG
- No uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg despite optimal medical therapy
- No preexisting thyroid abnormality (i.e., thyroid function tests that cannot be maintained in the normal range with medication)
- No known HIV- or AIDS-related illness or other active infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy or chemotherapy
- At least 4 weeks since prior major surgery
- No other concurrent investigational drugs
- No concurrent participation in another clinical trial (supportive care trials or non-treatment trials [e.g., quality of life] allowed)
- No concurrent therapeutic doses of warfarin (low-dose warfarin ≤ 2 mg once daily for thromboembolic prophylaxis allowed)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sunitinib
This is a phase II trial of Sunitinib in patients with metastatic urothelial carcinoma.
Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks followed by a two-week rest period for the initial population.
A second cohort of patients will be enrolled, who will receive 37.5 mg of sunitinib orally, on a continuous dosing schedule.
Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered.
Re-staging imaging studies will be performed after every cycle of treatment during the first 4 cycles and subsequently after every other cycle.
Patients may continue on study as long as they are tolerating therapy and in the absence of disease progression.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Objective Response
Time Frame: 2 years
|
Response rate as measured by RECIST criteria.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).
In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dean F. Bajorin, MD, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent bladder cancer
- stage IV bladder cancer
- metastatic transitional cell cancer of the renal pelvis and ureter
- recurrent transitional cell cancer of the renal pelvis and ureter
- transitional cell carcinoma of the bladder
- recurrent urethral cancer
- urethral cancer associated with invasive bladder cancer
- anterior urethral cancer
- posterior urethral cancer
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Ureteral Diseases
- Urethral Diseases
- Kidney Neoplasms
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Ureteral Neoplasms
- Urethral Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- 06-081
- MSKCC-06081
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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