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NCT00710970 · ClinicalTrials.gov registry record · Phase 2
Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment
A Phase 2 study of Urinary Bladder Neoplasms, sponsored by Seth Lerner.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 2
- Study locations
NCT00710970 is a Phase 2 study of Urinary Bladder Neoplasms that has completed, run by Seth Lerner. The registered enrollment target is 28 participants, below the 312-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00710970, a Phase 2 study of Urinary Bladder Neoplasms, has completed, sponsored by Seth Lerner.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 2
- Study locations
Study 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 RE
Conditions Studied
Interventions
- DRUG Tamoxifen
Study Locations (2)
Texas
- Baylor College Of Medicine - Houston
Other
- San Camillo and Forlanini Hospitals - Rome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00710970
The ClinicalTrials.gov registry entry for NCT00710970 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 312-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (91% lower). The listed sponsor is Seth Lerner, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Tamoxifen is the first listed.
NCT00710970 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Texas, Other.
Frequently Asked Questions
What is clinical trial NCT00710970 about?
NCT00710970 is a clinical study titled "Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment". 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 dis...
What is the current status of trial NCT00710970?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2007-01. Estimated completion is 2012-12.
What conditions does trial NCT00710970 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms.
What interventions are being tested in trial NCT00710970?
The interventions under investigation include: Tamoxifen (DRUG).
Who is sponsoring clinical trial NCT00710970?
This trial is sponsored by Seth Lerner, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00710970 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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