Tamoxifen in Treating Patients With Metastatic Bladder Cancer That Did Not Respond to Previous Chemotherapy
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
stage IV bladder cancer, transitional cell carcinoma of the bladder, recurrent bladder cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Primary Purpose: Treatment
Intervention
Name: tamoxifen citrate Type: Drug
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Status: Recruiting
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente - 323-865-0451
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States
Status: Recruiting
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor - 713-798-1297
Methodist Hospital
Houston, Texas, United States
Status: Recruiting
Contact: Joy Banerjee - 713-798-4479
Veterans Affairs Medical Center - Houston
Houston, Texas, United States
Status: Recruiting
Contact: Contact Person - 713-794-7111
Azienda Ospedaliera S. Camillo-Forlanini
Rome, Italy
Status: Recruiting
Contact: Cora N. Sternberg, MD, FACP - 39-06-5870-4580 - cstern@mclink.it
Start Date
July 2005
Sponsors
Baylor College of Medicine
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page