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Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
This study is ongoing, but not recruiting participants.
First Received: November 8, 2006   Last Updated: April 3, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00397488
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: sunitinib malate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as measured by RECIST criteria [ Designated as safety issue: No ]
  • Safety and toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: September 2006
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397488

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Dean F. Bajorin, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Dean F. Bajorin )
Study ID Numbers: CDR0000510910, MSKCC-06081
Study First Received: November 8, 2006
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00397488     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
anterior urethral cancer
posterior urethral cancer
recurrent urethral cancer
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
urethral cancer associated with invasive bladder cancer

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Angiogenesis Inhibitors
Recurrence
Carcinoma
Renal Cancer
Urologic Diseases
Sunitinib
Kidney Neoplasms
Urethral Cancer
Urethral Neoplasms
Bladder Neoplasm
Kidney Diseases
Ureteral Neoplasms
Transitional Cell Carcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antineoplastic Agents
Physiological Effects of Drugs
Ureteral Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Sunitinib
Therapeutic Uses
Urethral Diseases
Growth Inhibitors
Kidney Diseases
Angiogenesis Modulating Agents
Neoplasms by Histologic Type
Growth Substances
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Urethral Neoplasms
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 01, 2009