Status:
COMPLETED
Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment
Lead Sponsor:
Seth Lerner
Collaborating Sponsors:
AstraZeneca
Cytogen Corporation
Conditions:
Urinary Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The major objective of this two-stage phase II study is to determine whether tamoxifen is deserving of further study in metastatic bladder cancer. Tamoxifen is expected to function as a cytostatic (an...
Eligibility Criteria
Inclusion
- Patients previously diagnosed with bladder cancer who have already received 1-2 systemic therapy regimens (chemotherapy or biological therapy or both) but including at least one chemotherapy regimen.
- Patients who have had the cancer spread to other parts of the body.
- Patients must have adequate liver function.
Exclusion
- Patients who have uncontrolled nervous system metastasis
- Patients who are pregnant
- Patients who have had systemic therapies within the past 4 weeks
- Patients who plan to have major surgery within 2 weeks
- Patients who have Grade III/IV heart problems
- Patients who have severe and/or uncontrolled medical disease.
- Patients who might be at high risk for deep vein thrombosis
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00710970
Start Date
January 1 2007
End Date
December 1 2012
Last Update
January 24 2022
Active Locations (2)
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1
Baylor College Of Medicine
Houston, Texas, United States, 77030
2
San Camillo and Forlanini Hospitals
Rome, Italy