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H-16848 - Phase II Pilot Study With Correlative Markers of Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Urinary Bladder Neoplasms

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Trial Information

H-16848 - Phase II Pilot Study With Correlative Markers of Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

Seth P. Lerner, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Institutional Review Board

Study ID:

H-16848

NCT ID:

NCT00710970

Start Date:

January 2007

Completion Date:

January 2013

Related Keywords:

  • Urinary Bladder Neoplasms
  • Urinary Bladder Neoplasms
  • Previous Chemotherapy
  • Tamoxifen
  • Anti-tumor activity
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell

Name

Location
Baylor College of Medicine Houston, Texas  77030