- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710970
Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment
H-16848 - Phase II Pilot Study With Correlative Markers of Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Rome, Italy
- San Camillo and Forlanini Hospitals
-
-
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Freedom From Progression of Cancer at 4 Months
Time Frame: 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. |
Estimated from date of starting therapy until 4 months but up to progression or death which ever comes first.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seth P. Lerner, M.D., Baylor College of Medicine
Publications and helpful links
General Publications
- Kim HT, Kim BC, Kim IY, Mamura M, Seong DH, Jang JJ, Kim SJ. Raloxifene, a mixed estrogen agonist/antagonist, induces apoptosis through cleavage of BAD in TSU-PR1 human cancer cells. J Biol Chem. 2002 Sep 6;277(36):32510-5. doi: 10.1074/jbc.M202852200. Epub 2002 Jun 25.
- Shen SS, Smith CL, Hsieh JT, Yu J, Kim IY, Jian W, Sonpavde G, Ayala GE, Younes M, Lerner SP. Expression of estrogen receptors-alpha and -beta in bladder cancer cell lines and human bladder tumor tissue. Cancer. 2006 Jun 15;106(12):2610-6. doi: 10.1002/cncr.21945.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Raloxifene Hydrochloride
- Tamoxifen
Other Study ID Numbers
- H-16848
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Bladder Neoplasms
-
Peking University First HospitalRecruitingUrinary Bladder Cancer | Bladder Cancer | Bladder Neoplasms | Bladder Tumors | Neoplasms, BladderChina
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Bristol-Myers SquibbRecruitingUrinary Bladder Cancer | Invasive Bladder CancerNetherlands
-
GlaxoSmithKlineCompletedNeoplasms, Urinary BladderBelgium
-
Memorial Sloan Kettering Cancer CenterPfizerCompletedBladder Cancer | Urinary BladderUnited States
-
Mansoura UniversityCompletedBladder Cancer | Bladder Disease | Bladder Neoplasm | Micro-RNAEgypt
-
Zhujiang HospitalRecruiting
-
Chinese University of Hong KongUnknownUrinary Bladder TumorHong Kong
-
Medical University of ViennaUniversity of Turin, ItalyRecruitingT1 Urinary Bladder CancerAustria
-
Betul KartalBağcılar Eğitim ve Araştırma HastanesiRecruiting
-
Diskapi Teaching and Research HospitalCompleted
Clinical Trials on Tamoxifen
-
Institut Cancerologie de l'OuestActive, not recruiting
-
Northwestern UniversityNational Cancer Institute (NCI)CompletedEstrogen Receptor-positive Breast Cancer | Ductal Breast Carcinoma in SituUnited States
-
Seoul National University HospitalRecruitingHormone Receptor-positive Breast Cancer | Premenopausal Breast CancerKorea, Republic of
-
European Institute of OncologyIstituto Oncologico Veneto IRCCS; Ente Ospedaliero Ospedali Galliera; Istituto...Not yet recruitingDuctal Carcinoma in Situ | RAD51C Gene Mutation | RAD51D Gene Mutation | PALB2 Gene Mutation | Lobular Carcinoma in Situ | ATM Gene Mutation | CDH1 Gene Mutation | CHEK2 Gene Mutation | BRCA MutationItaly
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedBreast Cancer | Stage IV Breast CancerUnited States, Canada, Peru
-
National Cancer Center, KoreaUnknown
-
Northwestern UniversityNational Cancer Institute (NCI); BHR Pharma, LLCRecruitingEstrogen Receptor Positive | Ductal Breast Carcinoma In SituUnited States
-
The Methodist Hospital Research InstituteMillennium Pharmaceuticals, Inc.CompletedEstrogen Receptor Positive Breast CancerUnited States
-
Kafrelsheikh UniversityNot yet recruiting
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Breast Carcinoma | Stage IV Breast Cancer AJCC v6 and v7 | Stage III Breast Cancer AJCC v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7United States