Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Bladder Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm Receiving 25mg Tamoxifen

Group Type EXPERIMENTAL

Tamoxifen

Intervention Type DRUG

Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.

Interventions

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Tamoxifen

Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.

Intervention Type DRUG

Other Intervention Names

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raloxifene

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No