Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00880334
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact
Status	Completed
Phase	Phase 2
Start date	September 2006
Completion date	May 2015

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06034015` - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers	Phase 1
Recruiting	`NCT04235764` - En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Completed	`NCT02371447` - VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer	Phase 1/Phase 2
Recruiting	`NCT04081246` - Transurethral Modified En Bloc Resection For Large Bladder Tumours.	N/A
Recruiting	`NCT06059547` - Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer	Phase 2
Terminated	`NCT04779489` - Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer	N/A
Not yet recruiting	`NCT04493489` - Propranolol Adjuvant Treatment of Bladder Cancer	Phase 2
Completed	`NCT03520231` - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases	Phase 2
Recruiting	`NCT04537221` - Nordic Cystectomy Study III - Transfusion
Withdrawn	`NCT03007771` - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia	Phase 1
Completed	`NCT01955408` - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment	N/A
Completed	`NCT04487457` - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Recruiting	`NCT05562791` - A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer	Phase 1
Completed	`NCT00199849` - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine	Phase 1
Completed	`NCT02781428` - To Detect the Sensitivity of the UroMark Assay
Recruiting	`NCT04738630` - Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer	Phase 2
Completed	`NCT03980041` - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)	Phase 2
Active, not recruiting	`NCT03978624` - Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer	Phase 2
Completed	`NCT04534309` - Behavioral Weight Loss Program for Cancer Survivors in Maryland	N/A