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

Bladder Cancer Clinical Trial

Official title:

Phase II Study of Tamoxifen for Progressive Metastatic Bladder Cancer Following Previous Platinum-Based Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00589017
• Other study ID #: CDR0000581181
• Secondary ID: BCM-H16848
• Status: Recruiting
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: July 7, 2009
• Start date: July 2005

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• tamoxifen citrate

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera S. Camillo-Forlanini	Rome
United States	Dan L. Duncan Cancer Center at Baylor College of Medicine	Houston	Texas
United States	Methodist Hospital	Houston	Texas
United States	Veterans Affairs Medical Center - Houston	Houston	Texas
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4-month freedom from progression (stable disease, partial response, or complete response)			No