Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801644
• Other study ID #: Bladder Cancer-001
• Secondary ID: Bladder Cancer-0
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: February 28, 2013
• Start date: April 2007
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Barmherzige Brüder Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

Description:

Patients with locally advanced transitional cell bladder cancer receive 3 cycles of neoadjuvant gemcitabine/cisplatin before radical cystectomy.

Patients with histologically confirmed clinical stage T2-T4a, N0-2 bladder cancer are going to be included. After CT scan of the thorax and abdomen plus MRI of the pelvis patient receive chemotherapy.

Pathologic response rate will be assessed after surgery by the institutional pathologic review. Safety is going to be assessed according to the National Cancer Institute Common Toxicity Criteria (CTC,version 3.0).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age

• histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• bone marrow reserve (neutrophil count >1500 cells per µL,platelet count >100 000 per µL) count

• hepatic function (serum bilirubin <2,5 times the upper limit of normal, serum aminotransferase =2,5 times the upper limit of normal).

• renal function with a creatinine clearance >60ml/min

Exclusion Criteria:

• metastatic disease

• serious or uncontrolled concurrent medical illness

• pregnancy

• history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma)

• non-transitional cell bladder cancer

• creatinine clearance <60ml/min

Study Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• gemcitabine plus cisplatin
gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion followed by cisplatin 70 mg/m2 on day 1 as an 2 hour infusion

Locations

Country	Name	City	State
Austria	Barmherzige Brüder Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Barmherzige Brüder Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Dash A, Pettus JA 4th, Herr HW, Bochner BH, Dalbagni G, Donat SM, Russo P, Boyle MG, Milowsky MI, Bajorin DF. A role for neoadjuvant gemcitabine plus cisplatin in muscle-invasive urothelial carcinoma of the bladder: a retrospective experience. Cancer. 2008 Nov 1;113(9):2471-7. doi: 10.1002/cncr.23848. — View Citation

Tolerability of neoadjuvant chemotherapy with gemcitabine plus cisplatin in elderly (older than age 65) patients (pts) with muscle-invasive urothelial cancer. D. Niedersuess-Beke, B. Gruenberger, T. Puntus, W. Bauer, M. Lamche, P. Schramek, J. G. Meran; B

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	progression free survival (PFS)	pfs will be assessed avery 3 months in the first year after radical cystectomy, every 6 months in the second year, and yearly from the 3rd year up to a minimum follow up of 5 years	up to 5 years after including the last patient	No
Primary	pathologic response rate	evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy	at time of surgery	No
Secondary	safety, number of participants with adverse events and grade of adverse events	to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer	adverse events will be evaluated after every 6 months	Yes