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Sorafenib in Treating Patients With Advanced or Metastatic Cancer of the Urinary Tract
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112671
  Purpose

RATIONALE: Sorafenib 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 how well sorafenib works in treating patients with advanced or metastatic cancer of the urinary tract.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: sorafenib tosylate
Phase II

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of BAY 43-9006 in Advanced or Metastatic Urothelial Cancer (Transitional Cell Cancer of the Bladder, Ureter and Renal Pelvis)

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

Primary Outcome Measures:
  • Objective tumor response (complete and partial) as defined by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate and duration of stable disease [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Survival at 1 year [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment: 33
Study Start Date: August 2005
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of sorafenib, in terms of response rate and stable disease rate in patients with advanced or metastatic transitional cell carcinoma of the bladder, ureter, or renal pelvis.
  • Determine the toxicity of this drug in these patients.
  • Determine the response duration and time to progression in patients treated with this drug.
  • Correlate baseline and post-treatment levels of pERK, pAKT, VEGFR2, CD31, Ki-67/MIB-1, and cleaved caspase 3, with clinical outcome in patients treated with this drug.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed within 3 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study within 8-16 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed transitional cell carcinoma of the bladder, ureter, or renal pelvis

    • Advanced or metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • The following are not considered measurable disease:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
  • Tumor accessible for biopsy
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1 OR
  • Karnofsky 70-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)

Renal

  • Creatinine < 1.5 times ULN OR
  • Creatinine clearance ≥ 45 mL/min

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina pectoris
  • No active cardiomyopathy
  • No unstable ventricular arrhythmia
  • No other cardiac arrhythmia
  • No uncontrolled hypertension

Gastrointestinal

  • No active peptic ulcer disease
  • No malabsorption syndrome
  • No gastrointestinal (GI) tract disease that would preclude ability to take oral medication
  • No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • No requirement for IV alimentation
  • Able to swallow and retain oral medication

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No ongoing or active serious infection
  • No uncontrolled psychotic disorders
  • No psychiatric illness or social situation that would preclude study compliance
  • No other active malignancy within the past 5 years except adequately treated carcinoma in situ or nonmelanoma skin cancer
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib
  • No other uncontrolled illness
  • No other serious medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy (including adjuvant or neoadjuvant chemotherapy)

    • At least 6 weeks for nitrosoureas or mitomycin

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy to the sole site of measurable disease

Surgery

  • No prior surgical procedures affecting absorption

Other

  • No prior systemic therapy for advanced or metastatic disease
  • At least 7 days since prior and no concurrent administration of any of the following:

    • Rifampin
    • Phenytoin
    • Carbamazepine
    • Phenobarbital
    • Hypericum perforatum (St. John's wort)
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) allowed provided requirements for PT, INR, or PTT are met
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112671

Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Study Chair: Srikala Sridhar, MD, FRCPC, MSC Princess Margaret Hospital, Canada
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Sridhar SS, Winquist E, Eisen A, et al.: A phase II study of first-line sorafenib (Bay 43-9006) in advanced or metastatic urothelial cancer: a trial of the PMH phase II Consortium. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-340, 2008.

Study ID Numbers: CDR0000429647, PMH-PHL-036, NCI-7062
Study First Received: June 2, 2005
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00112671  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
metastatic transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
recurrent bladder cancer
recurrent transitional cell cancer of the renal pelvis and ureter

Study placed in the following topic categories:
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Renal cancer
Kidney cancer
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Neoplasm Metastasis
Kidney Diseases
Sorafenib
Ureteral Neoplasms
Urinary tract neoplasm
Bladder neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009