Status:
COMPLETED
Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Pfizer
Conditions:
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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 w...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00397488
Start Date
September 1 2006
End Date
February 1 2012
Last Update
January 25 2016
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021