NCT00933374

Trial to Evaluate Paclitaxel Plus RAD001 in Urothelial Carcinoma

A Single Arm, Multi-center Phase II Trial to Evaluate Paclitaxel Plus RAD001 in Urothelial Carcinoma After Failure of Prior Platin-based Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm open- label phase II- trial evaluating safety and efficacy of paclitaxel and RAD001 in patients with metastatic urothelial bladder cancer who failed prior platin-based systemic therapy.

Detailed description

The screening phase for checking eligibility and evaluation of the patient prior start of study treatment will last up to 21 days.Tumor histology must be predominant urothelial carcinoma and confirmed histological or cytological.Patients who meet the inclusion criteria will be treated with paclitaxel 175 mg/m2 every 3 weeks and RAD001 10 mg once daily. Each cycle will use the combination of paclitaxel 175 mg/m2 3-weekly with RAD001 10 mg daily starting at day 1 of a 21 days treatment cycle. Additional visits after day 1 are performed at day 8 and day 15 of each cycle Assessment of safety and toxicity will be performed at every visit. Patients will be treated until no signs of clinical or radiological progression are evident and the study treatment is well tolerated for a maximum of 6 cycles.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	paclitaxel	Paclitaxel (175 mg/m3)will be administered as a 3 hour continuous IV infusion after standard premedication every 3 weeks
DRUG	RAD001	10 mg RAD001 once daily starting at day 1 of a 21 days treatment cycle

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-01-01
• Completion: 2013-09-01
• First posted: 2009-07-07
• Last updated: 2015-03-18

Locations

6 sites across 1 country: Germany