Phase II Study of a Novel Taxane (Cabazitaxel-XRP6258) in Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
A substantial number of patients with lung cancer progress after first line treatment and
require second line chemotherapy. Lung cancer appears to account for 40-50% of all known
brain metastasis. The incidence of brain metastases among lung cancer patients ranges from
16-20%. Chemotherapy has had limited utility due to problems crossing the blood brain
barrier.
Currently there are three drugs approved by the FDA for second line treatment of NSCLC but
each has distinct toxicities. Cabazitaxel-XRP6258 is a potent novel taxane with enhanced
activity against an increased number of cell lines including lung, prostate, colon,
pancreas, head and neck, kidney, gastric, glioblastoma, and melanoma. It also has the
ability to cross the blood brain barrier. Cabazitaxel-XRP6258 was found to have an improved
antiproliferative activity than other chemotherapy agents against insensitive cell lines.
The Phase I studies of Cabazitaxel-SRP6258 have determined dosage and schedule
recommendations in advanced NSCLC patients to be utilized for a Phase II multicenter study.
Subjects will be placed on one of two schedules (A or B) each with a specified dosage and
administration schedule. All subjects will be followed for survival/progression after every
2 cycles of therapy with imaging studies. A two stage design will be used for each of the
two schedules. Fourteen subjects will be accrued for each schedule in the first stage with
possible accrual of an additional 34 subjects per schedule depending upon the first stage
results.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Second line treatment objective response rate
Subjects who have failed first line chemotherapy for Stage IV NSCLC will be assessed for this second line treatment with Cabazitaxel-XRP6528. The primary objective is to show an objective response rate of greater than or equal to 15% for the second line treatment.
24 months
No
Francisco Robert, MD
Principal Investigator
University of Alabama at Birmingham
United States: Institutional Review Board
F110512012 (UAB 1021)
NCT01438307
September 2011
November 2014
Name | Location |
---|---|
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Georgia Cancer Center | Atlanta, Georgia 30060 |