The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence

Urothelial Carcinoma Clinical Trial

Official title:

The Effectiveness and Safety of Intravesical Docetaxel Instillation After Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy or Distal Ureterectomy in Upper Urinary Tract Urothelial Carcinoma: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209206
• Other study ID #: SeoulNUHUro
• Status: Recruiting
• Phase: Phase 2
• First received: June 30, 2017
• Last updated: December 21, 2017
• Start date: June 28, 2017
• Est. completion date: April 1, 2022

Study information

• Verified date: December 2017
• Source: Seoul National University Hospital
• Contact: Ja Hyeon Ku, M.D.,PH.D
• Phone: +82-2-2072-0361
• Email: randyku[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).

Description:

Approximately 20% to 50% of patients with upper urinary tract urothelial carcinoma (UUT-UC) experience bladder recurrence after nephroureterectomy. Although many agents have been administered for the prevention of bladder recurrence, the standard prophylactic treatment has yet to be established. A meta-analysis found that a single instillation of chemotherapy immediately after transurethral resection of bladder tumor (TURBT) significantly decreased the risk of recurrence in patients with bladder cancer. Indeed, a single early instillation of Docetaxel was found to reduce the post-TURBT bladder recurrence rate among patients with bladder cancer.

In this prospective, randomized study, the investigators evaluated the efficacy of a single, early, intravesical instillation of Docetaxel in the prevention of bladder recurrence after nephroureterectomy for UUT-UC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: April 1, 2022
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

Inclusion Criteria:

• Upper urinary tract urothelial cell carcinoma

• Hb>10g/dL, ANC >1500mm3, Platelet > 100K

• Total bilirubin : 1.5 times lower than the normal upper limit

• AST/ALT: 1.8 times lower than the normal upper limit

• Alkaline phosphatase: 1.8 times lower than the normal upper limit

Exclusion Criteria:

• Concomitant bladder tumor

• Patients diagnosed with bladder cancer within the last 3 years

• Previous history of hypersensitivity to Docetaxel

• Neurogenic Bladder

• Patients who received chemotherapy for cancer within the last 6 months

• Patients with active disease not fit for this study

• ANC <1500mm3

• Pregnant or lactating women

• Patients with severe hepatic dysfunction

• patients with severe renal impairment

• patients with hypersensitivity to mannitol, paraplatin, platinum compounds

• Patients with complications of infection

• Patients suspected of having infectious fever

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Recurrence
• Urothelial Carcinoma

Intervention

Drug:
• Docetaxel
Intravesical Instillation of Docetaxel (Docetaxel 75 mg diluted in 100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)
• Placebo Normal saline
Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Barlow L, McKiernan J, Sawczuk I, Benson M. A single-institution experience with induction and maintenance intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to bacille Calmette-Guérin therapy. BJU Int. 2009 Oct;104( — View Citation

Delto JC, Kobayashi T, Benson M, McKiernan J, Abate-Shen C. Preclinical analyses of intravesical chemotherapy for prevention of bladder cancer progression. Oncotarget. 2013 Feb;4(2):269-76. — View Citation

Ito A, Shintaku I, Satoh M, Ioritani N, Aizawa M, Tochigi T, Kawamura S, Aoki H, Numata I, Takeda A, Namiki S, Namima T, Ikeda Y, Kambe K, Kyan A, Ueno S, Orikasa K, Katoh S, Adachi H, Tokuyama S, Ishidoya S, Yamaguchi T, Arai Y. Prospective randomized ph — View Citation

Laudano MA, Barlow LJ, Murphy AM, Petrylak DP, Desai M, Benson MC, McKiernan JM. Long-term clinical outcomes of a phase I trial of intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to standard intravesical therapy. — View Citation

Lu S, Neoh KG, Kang ET, Mahendran R, Chiong E. Mucoadhesive polyacrylamide nanogel as a potential hydrophobic drug carrier for intravesical bladder cancer therapy. Eur J Pharm Sci. 2015 May 25;72:57-68. doi: 10.1016/j.ejps.2015.03.006. Epub 2015 Mar 13. — View Citation

Wu P, Zhu G, Wei D, Liu S, Walsh K, Li D, Harron U, Wang X, Ma H, Wan B, Sun L, Yang Z, Wang J. Prophylactic intravesical chemotherapy decreases bladder tumor recurrence after nephroureterectomy for primary upper tract urothelial carcinoma: A systematic r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence in bladder	Present of bladder recurrence after intervention in follow up cystoscopy or CT scan	2years
Secondary	Incidence of Treatment-Emergent Adverse Events	Present of adverse event after intervention	2years
Secondary	Overall Survival	Overall Survival rate during follow up period	2years
Secondary	Time to recurrence	Time to bladder recurrence after intervention in follow up cystoscopy or CT scan	2years