Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Cytogen Corporation
Information provided by (Responsible Party):
Seth Lerner, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00710970
First received: July 7, 2008
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Urinary Bladder Neoplasms
Drug: Tamoxifen
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: January 2007
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Receiving 25mg Tamoxifen Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710970

Locations
United States, Texas
Baylor College Of Medicine
Houston, Texas, United States, 77030
Italy
San Camillo and Forlanini Hospitals
Rome, Italy
Sponsors and Collaborators
Seth Lerner
AstraZeneca
Cytogen Corporation
Investigators
Principal Investigator: Seth P. Lerner, M.D. Baylor College of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Seth Lerner, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00710970     History of Changes
Other Study ID Numbers: H-16848
Study First Received: July 7, 2008
Results First Received: December 27, 2012
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Urinary Bladder Neoplasms
Previous Chemotherapy
Tamoxifen
Anti-tumor activity

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on April 15, 2014