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 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||H-16848 - Phase II Pilot Study With Correlative Markers of Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy|
- 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. [ Time Frame: To progression ] [ Designated as safety issue: No ]
- Sustained Stable Disease is Considered to be Clinically Important. Hence, 4-month Freedom From Progression (FFP) (Stable Disease + Partial Response + Complete Response) is Chosen as the Primary End-point Instead of Response Rate. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: Single Arm Receiving 25mg 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.
Other Name: raloxifene
|United States, Texas|
|Baylor College Of Medicine|
|Houston, Texas, United States, 77030|
|San Camillo and Forlanini Hospitals|
|Principal Investigator:||Seth P. Lerner, M.D.||Baylor College of Medicine|