Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

Carcinoma, Transitional Cell Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00172367
• Other study ID #: 930906
• Status: Withdrawn
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: September 25, 2008
• Start date: January 2006

Study information

• Verified date: November 2004
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell

Intervention

Drug:
• Lycopene

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of intermediate biomarker status after lycopene supplementation
Secondary	safety and tolerability