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
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: tamoxifen citrate
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Tamoxifen for Progressive Metastatic Bladder Cancer Following Previous Platinum-Based Chemotherapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 4-month freedom from progression (stable disease, partial response, or complete response) [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2005
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed 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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589017

Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente    323-865-0451      
United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor    713-798-1297      
Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Joy Banerjee    713-798-4479      
Veterans Affairs Medical Center - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Contact Person    713-794-7111      
Italy
Azienda Ospedaliera S. Camillo-Forlanini Recruiting
Rome, Italy, 00152
Contact: Cora N. Sternberg, MD, FACP    39-06-5870-4580    cstern@mclink.it   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Study Chair: Seth P. Lerner, MD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Seth P. Lerner, Dan L. Duncan Cancer Center at Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00589017     History of Changes
Other Study ID Numbers: CDR0000581181, BCM-H16848
Study First Received: December 21, 2007
Last Updated: July 7, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV bladder cancer
transitional cell carcinoma of the bladder
recurrent bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Tamoxifen
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014