Tamoxifen in Treating Patients With Metastatic Bladder Cancer That Did Not Respond to Previous Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00589017
First received: December 21, 2007
Last updated: July 7, 2009
Last verified: July 2009

December 21, 2007
July 7, 2009
July 2005
July 2010   (final data collection date for primary outcome measure)
4-month freedom from progression (stable disease, partial response, or complete response) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00589017 on ClinicalTrials.gov Archive Site
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Tamoxifen in Treating Patients With Metastatic Bladder Cancer That Did Not Respond to Previous Chemotherapy
Phase II Study of Tamoxifen for Progressive Metastatic Bladder Cancer Following Previous Platinum-Based Chemotherapy

RATIONALE: Tamoxifen may slow the growth of tumor cells and may be an effective treatment for patients with metastatic bladder cancer that did not respond to previous chemotherapy.

PURPOSE: This phase II trial is studying how well tamoxifen works in treating patients with metastatic bladder cancer that did not respond to previous chemotherapy.

OBJECTIVES:

Primary

  • To assess the 4-month freedom from progression in patients with progressive metastatic transitional cell carcinoma of the bladder treated with tamoxifen citrate.

Secondary

  • To determine the objective response rate.
  • To correlate response with estrogen-receptor status of the metastatic tumor.
  • To collect data on the toxicity and safety profile of this regimen.
  • To assess the overall survival.

OUTLINE: This is a multicenter study.

Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Tumor tissue samples are analyzed for tumor estrogen receptors a and b by immunohistochemical (IHC) staining. Tumor tissue and blood samples are stored for future correlative biomarker studies.

After completion of study treatment, patients are followed every 2 months for up to 6 months.

Interventional
Phase 2
Primary Purpose: Treatment
Bladder Cancer
  • Drug: tamoxifen citrate
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Not Provided
July 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma of the bladder
  • Evidence of progressive metastatic disease that is unresectable

    • Stage T4b, N1-3, or M1 disease
  • Must have received 1-2 prior systemic therapy regimens (chemotherapy, biological therapy, or both) that included at least one platinum-based chemotherapy regimen

    • Prior perioperative chemotherapy (adjuvant/neoadjuvant therapy) is considered one regimen
  • Bidimensionally measurable disease (including bone disease) of ≥ 10 mm on spiral CT scan or ≥ 20 mm on conventional CT scan
  • No uncontrolled CNS metastases

    • CNS metastases that have been previously treated with radiotherapy are allowed if patient is off corticosteroids

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Bilirubin ≤ 2.0 mg/dL
  • AST/ALT < 4 times upper limit of normal
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective barrier or other nonhormonal methods of contraception
  • No New York Heart Association class III-IV cardiac disease (i.e., congestive heart failure or myocardial infarction within the past 6 months)
  • No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
  • Not at high risk for deep vein thrombosis, as determined by the physician

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 2 prior systemic therapy regimens, including chemotherapy and/or biological therapy
  • More than 4 weeks since prior systemic therapy
  • More than 2 weeks since prior major surgery
Both
18 Years and older
No
United States,   Italy
 
NCT00589017
CDR0000581181, BCM-H16848
Not Provided
Seth P. Lerner, Dan L. Duncan Cancer Center at Baylor College of Medicine
Baylor College of Medicine
Not Provided
Study Chair: Seth P. Lerner, MD Baylor College of Medicine
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP