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

Inclusion 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