NCT00880334

Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this research study the investigators are looking to see if the combination of docetaxel plus Vandetanib is effective in the treatment of metastatic transitional cell carcinoma (TCC). Docetaxel is a chemotherapy drug that kills cancer cells that are dividing. It is widely used in TCC. Vandetanib is a drug that is believed to stop new blood vessels from forming around cancer cells. The combination of docetaxel and Vandetanib has been studied in people with lung cancer and found to be helpful in killing cancer cells. Thus, this study is looking at people with TCC, to see if the combination of docetaxel plus Vandetanib is better or worse then docetaxel alone.

Detailed description

* Because no one knows which of the study options is best, and all of the options are considered equally likely to work, participants will be randomized into one of two study groups: docetaxel plus Vandetanib or docetaxel plus placebo. * Each treatment cycle lasts three weeks during which time the participant will be taking Vandetanib or placebo once a day, every day. On Day 1 of each cycle (a cycle is 21 days), participants will receive docetaxel as an infusion through a vein in the arm over one hour. * On Day 1 of every cycle the following tests and procedures will be performed: physical exam and blood tests. On day 1 and on Day 8 of the first cycle only, participants will have an ECG. Every 6-9 weeks (every 2 to 3 cycles), the participants tumor will be assessed by x-ray, CT scan, bone scan, and/or MRI.

Conditions

• Transitional Cell Carcinoma
• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Given intravenously on Day 1 of each 21-day cycle
DRUG	vandetanib	taken orally once a day, every day
DRUG	Placebo	Taken orally once a day every day

Timeline

• Start date: 2006-09-01
• Primary completion: 2013-12-01
• Completion: 2015-05-01
• First posted: 2009-04-13
• Last updated: 2018-09-18
• Results posted: 2014-06-04

Locations

3 sites across 1 country: United States