NCT02197897

Brief Summary

Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 13, 2021

Completed
Last Updated

January 13, 2021

Status Verified

December 1, 2020

Enrollment Period

2.5 years

First QC Date

July 21, 2014

Results QC Date

July 21, 2020

Last Update Submit

December 18, 2020

Conditions

Bladder Cancer

Keywords

Tamoxifen citrateBladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion

    Evaluate the efficacy of tamoxifen for treatment of low/intermediate-risk bladder tumors, utilizing the RECIST criteria combined with the final biopsy of the marker lesion or the bed of the lesion in case of a complete response

    2.5 years

Study Arms (1)

Tamoxifen

EXPERIMENTAL

As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.

Drug: Tamoxifen Citrate

Interventions

Tamoxifen CitrateDRUG

Single-center, two-stage phase-II clinical trial (Simon design)

Also known as: Nolvadex
Tamoxifen

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females age 21 or older. Histologic evidence of urothelial carcinoma of the bladder. Low/Intermediate-risk papillary urothelial carcinoma of the bladder, at initial occurrence or recurrent with \>6 months interval free of disease.
  • Patients with multifocal tumors must have resectable lesions. Patients may be treatment-naïve or have failed 1 previous regimen of intravesical therapy.
  • At least one endoscopically measurable tumor 6 - 10mm in diameter. Adequate hepatic and renal function. Patient or authorized proxy needs to have signed the informed consent form.

You may not qualify if:

  • Patients with sessile appearing tumors, which may be invasive or high-grade. Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract.
  • Plans for pelvic radiation while participating in the study. Concurrent use of warfarin, heparin, or chronic use of NSAIDs, including aspirin (other than cardioprotective doses of 80mg daily) within 30 days prior to registration or during the trial.
  • Concurrent use of selective serotonin reuptake inhibitors or aromatase inhibitors.
  • Chronic or acute renal or hepatic disorder or any other condition, medical or psychological that, in the opinion of the investigator, could jeopardize the subject's safe participation.
  • Any other investigational drug within 30 days prior to registration and during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Harris Health System

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Guilherme Godoy
Organization
Baylor College of Medicine
godoy@bcm.edu
713-798-4001

Study Officials

  • Guilherme Godoy, M.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Guilherme Godoy, M.D.

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 23, 2014

Study Start

April 1, 2015

Primary Completion

September 12, 2017

Study Completion

June 28, 2019

Last Updated

January 13, 2021

Results First Posted

January 13, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)