NCT01852578

Cabazitaxel in Relapsed and Metastatic NSCLC

A Pilot Phase II Trial of Cabazitaxel in Patients With Metastatic NSCLC Progressing After Docetaxel-based Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Cabazitaxel	Cabazitaxel: 25 mg/m² i.v over 1 h on day 1. Cycles repeated ever 3 weeks

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-05-13
• Last updated: 2015-09-28

Locations

5 sites across 1 country: Greece