Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment
- Registration Number
- NCT00710970
- Lead Sponsor
- Seth Lerner
- 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 (and not cytotoxic) agent, and may produce more disease stability than regression. Sustained stable disease is considered to be clinically important and the more likely event. Hence, 4-month freedom from progression is chosen as the primary end-point instead of response rate. Freedom from progression is defined as the period from start of therapy to the time of objective radiologic progression. A total of 25 subjects will be enrolled, 15 during stage 1 and 10 during stage 2 of a two-stage minimax design phase II study.
Pre-therapy evaluation (within 3 weeks of initiation of therapy):
* History and physical examination (H and P)
* Performance status (PS) assessment
* CBC (complete blood counts)
* CMP (complete metabolic profile)
* Pregnancy test (in women younger than 50)
* Computed tomography (CT) scan of the chest, abdomen and pelvis
* Bone scan if bone pain or raised alkaline phosphatase
* Biopsy (may use previous biopsy specimen)
* Samples of plasma from the routine CBC and CMP will be banked indefinitely for future biomarker studies at the Scott Department of Urology.
Treatment plan: Therapy will be administered as an outpatient. Tamoxifen is administered at 20 mg/day as a single daily oral dose. Clinical assessment of patients by a history and physical examination will be performed every 4 weeks (one cycle). Objective radiological assessment of response will be made every 8 weeks or earlier if clinically indicated. A CT (computerized tomography) scan of the abdomen, pelvis and chest will be performed at baseline and every 2 cycles. A response is confirmed by repeating the scans in 4 weeks. Bone scan is performed if the patient complains of new bone pain or has raised alkaline phosphatase. A radiologist who is blinded to the treatment regimen reads the scans. The RECIST criteria are used to define response. Tamoxifen is continued until progressive disease or intolerable side effects occur.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Receiving 25mg Tamoxifen Tamoxifen -
- Primary Outcome Measures
Name Time Method Number of Participants With Freedom From Progression of Cancer at 4 Months Estimated from date of starting therapy until 4 months but up to progression or death which ever comes first. Clinical Assessments were performed every 4 weeks and imaging every 8 weeks or earlier if indicated.
Patients were followed every month for clinical symptoms and signs of progression.
Patients underwent Radiographic CT scans every 8 weeks to look for progression.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
San Camillo and Forlanini Hospitals
🇮🇹Rome, Italy
Baylor College Of Medicine
🇺🇸Houston, Texas, United States