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

Phase 2
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

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



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


- 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

Inclusion Criteria


- 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


- 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

- 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


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

4-month freedom from progression (stable disease, partial response, or complete response)

Safety Issue:


Principal Investigator

Seth P. Lerner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor College of Medicine



Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • recurrent bladder cancer
  • Urinary Bladder Neoplasms



USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Houston Houston, Texas  77030
Methodist Hospital Houston, Texas  77030
Dan L. Duncan Cancer Center at Baylor College of Medicine Houston, Texas  77030