Phase IV Randomized Trial of Pemetrexed Followed by Docetaxel or in Reverse Sequence in Non-small-cell Lung Cancer Patients Failed Previous Chemotherapy
Docetaxel was the first third-generation anti-cancer drug found to have activity in
second-line chemotherapy for NSCLC, with a prolongation of patient survival in phase III
randomized trials comparing docetaxel with vinorelbine or ifosfamide, or with the best
supportive care, for NSCLC patients who have failed previous chemotherapy; thus, it has been
recommended for the second-line treatment of NSCLC. Four years after these trials,
pemetrexed showed similar activity with less toxicity, when compared with docetaxel
treatment in a phase III randomized trial of NSCLC patients previously treated with
chemotherapy.
Pemetrexed is a multitargeted antifolate which exhibits clinical activity in a variety of
solid tumors, especially malignant mesothelioma and NSCLC. It inhibits thymidylate synthase,
dihydrofolate reductase and glycinamide ribonucleotide formyl transferase. Pemetrexed has
confirmed activity against previously chemotherapy-treated NSCLC and has a better toxicity
profile than docetaxel, in which study docetaxel dosage used was 75 mg/m2 intravenous
infusion (IV) every 3 weeks. However, docetaxel dosage used in Japan and Taiwan is usually
60 mg/m2 every 3 weeks.
Whether or not toxicity profiles of these two different drugs in same individual patients is
similar to findings of patients who received specific drug only is unknown, so is unknown of
toxicity profiles of docetaxel 60 mg/m2 every 3 weeks comparing alimta 500 mg/m2 every 3
weeks. Present phase II randomized clinical trial is designed to answer these questions,
with addition of information about whether or not sequential therapy can prolong
disease-free and overall survival.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of grade III or IV leukopenia during treatment
one year
Yes
Yuh-Min Chen, MD, PhD.
Principal Investigator
Chest Department, Taipei VGH
Taiwan: Department of Health
97-02-09
NCT01442909
March 2008
September 2009
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