Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 22, 2011

Primary Completion Date

July 21, 2015

Study Completion Date

July 21, 2020

Conditions
Prostate Cancer
Interventions
DRUG

Cabazitaxel

"Administered weekly on the same day of radiation according to the following infusion levels:~Level 1 (Initial): 4 mg/m2; Level -1: 2 mg/m2; Level 2: 6 mg/m2; Level 3: 8 mg/m2; Level 4: 10 mg/2;"

RADIATION

Intensity Modulated Radiation Therapy (IMRT)

Starts 8 weeks after initiation of androgen deprivation therapy, given daily at 1.8 Gy for a total of 75.6 Gy

DRUG

Anti-Androgen Therapy: Bicalutamide

"* Taken once daily by mouth starting between 2 weeks and 1 day before the first administration of Luteinizing Hormone-Releasing Hormone (LHRH)~* Will continue once daily until the final day of IMRT"

GENETIC

Luteinizing Hormone-Releasing Hormone (LHRH) Agonist

"* First administration will occur 1 day to 2 weeks after the start of Bicalutamide and 8 weeks prior to the start of IMRT (+/- 4 weeks)~* Will continue for 24 months after IMRT~* Total administered duration and agent used must be documented on the case report form"

Trial Locations (1)

19107

Thomas Jefferson University, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER