NSCLC Clinical Trial
Official title:
A Pilot Phase II Trial of Cabazitaxel in Patients With Metastatic NSCLC Progressing After Docetaxel-based Treatment
The investigators propose to study the single agent activity of Cabazitaxel in a Phase II trial of subjects with relapsed or refractory non-small cell lung cancer pretreated with docetaxel, given the fact of its significant activity and its acceptable toxicity profile.
Non small cell lung cancer represents the second most common type of cancer in both men and
women in the Western world. The availability of new active regimens in the first line
setting has prompted several investigators to consider second line therapy for patients with
advanced NSCLC, since a substantial percentage of patients maintain a good PS upon
recurrence. On the basis of the results of phase III trials docetaxel, erlotinib, gefitinib,
or pemetrexed are considered as "standard" choices for second-line therapy.
However, despite the increased availability of different drugs, NSCLC remains a devastating
disease with median OS which rarely exceeds 12 months.
Preclinical data of cabazitaxel have demonstrated antitumor activity in models resistant to
paclitaxel and docetaxel. In cell lines resistant to cytotoxic agents, cabazitaxel induced
further tumor regression.
The recommended phase 2 doses for Cabazitaxle were 20 and 25 mg/m2. Cabazitaxel showed
antitumor activity in solid tumors including docetaxel-refractory metastatic
castration-resistant prostate cancer and breast cancer.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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