Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00172367

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma.

Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Transitional Cell	Drug: Lycopene	Phase 2

Detailed Description

This is a renal function-stratified phase II chemoprevention trial. After 8 weeks of a run-in and washout period, participants will take lycopene, 30 mg per day for 12 weeks. The expression of intermediate biomarkers will be determined upon study entry after 8 weeks of run-in/washout, and after 6 and 12 weeks of lycopene supplementation. It takes at least 20 weeks to complete the course.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

changes of intermediate biomarker status after lycopene supplementation []

Secondary Outcome Measures

safety and tolerability []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients have pathologically-proven urothelial carcinoma (UC) with a clinical stage <= T3N0M0
Patients have no visible or identifiable residual UC after treatment with a life expectancy of > 6 months
Patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded)
No other active malignancy. Patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year.
Patients are able to take lycopene capsules orally.
Patients who sign and give informed consents and are willing to conform to the scheduled sampling of the blood, urine and/or tissue

Exclusion Criteria:

Patients who have clinical stage > T3N0M0 or metastatic disease
Positive urine cytology. Patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). If no recurrent or residual tumors are found, patients are still eligible for the study.
Patients who have ever received systemic chemotherapy within 12 months
Patients who have gastrointestinal malabsorption regardless of the etiology
Have known allergic reaction to tomato or lycopene
Patients who are participating or will participate in other clinical trials
Patients who have active urinary tract infection can not be accrued until infection is effectively controlled
Patient's age is less than 18 years