Lung Cancer Clinical Trial
Official title:
0822GCC 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
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).
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.
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