Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer
The primary objective is to determine the anti-tumor activity of the combination of apricoxib + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel (P/DC) or pemetrexed (P/PE) as measured by progression free survival in patients with Stage IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).
Non Small Cell Lung Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Either Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer Patients|
- Progression Free Survival [ Time Frame: From the date of randomization until the first date that recurrent or progressive disease is objectively documented. ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||July 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Apricoxib 400mg once a day plus Docetaxel 75mg/m2 or Pemetrexed 500mg/m2 every 21 days(Treating physician will determine chemotherapy drug as per his usual practice).
Oral apricoxib tablets will be provided as white or off-white film-coated tablets available in 100mg strength to be taken every day + docetaxel or pemetrexed administered as an intravenous infusion on the first day of each 21 day cycle.
Placebo Comparator: 2
Placebo once a day plus Docetaxel 75mg/m2 or Pemetrexed 500mg/m2 every 21 days(Treating physician will determine chemotherapy drug as per his usual practice).
Oral placebo tablets will be provided as white or off-white film-coated tablets to be taken every day + docetaxel or pemetrexed administered as an intravenous infusion on the first day of each 21 day cycle.
Patients diagnosed with advanced non-small cell lung cancer that has not responded to platinum-based chemotherapy are eligible to particvpate in this study.
Current standard treatments for this type of lung cancer are generally not effective in preventing the cancer from growing. The purpose of this study is to see if adding the drug apricoxib to standard chemotherapy is effective in treting NSCLC. Apricoxib is an investigational drug. Investigational means that it is not approved by the Food and Drug Administration (FDA). Laboratory studies suggest that apricoxib may be useful in the treatment of cancer . This is seen particularly when it is combined with chemotherapy drugs. However, this has not been proven in humans.
Laboratory evidence indicates that apricoxib may benefit patients whose disease over-produces a substance called COX-2. COX-2 can be detected in the urine as a substance called PGE-M (prostaglandin E metabolite). It is thought that patients who have a PGE-M level in the urine that decreases by at least half after taking apricoxib may benefit more than patients whose urine PGE-M decreases by less than half after apricoxib.
This study evaluated whether adding apricoxib to standard chemotherapy treatment will improve outcomes in patients with non-small cell lung cancer whose urine PGE-M decreases at least 50% after taking apricoxib. Apricoxib or placebo was added to either docetaxel or pemetrexed treatment.
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Mercy Research Institute|
|Miami, Florida, United States, 33133|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Maryland|
|University of Maryland Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|United States, New York|
|Weill Medical Cornell University|
|New York, New York, United States, 10065|
|Stony Brook Cancer Center (SUNY)|
|Stony Brook, New York, United States, 11794|
|United States, Oregon|
|Providence Portland Medical Center|
|Portland, Oregon, United States, 97213|
|United States, Pennsylvania|
|Abramson Cancer Center of Uof Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, West Virginia|
|West Virginia University Clinical Trials Research Unit|
|Morgantown, West Virginia, United States, 26506|
|Principal Investigator:||Martin J Edelman||University of Maryland Greenebaum Cancer Center|