Cabazitaxel in Relapsed and Metastatic NSCLC
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|ClinicalTrials.gov Identifier: NCT01852578|
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|NSCLC||Drug: Cabazitaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase II Trial of Cabazitaxel in Patients With Metastatic NSCLC Progressing After Docetaxel-based Treatment|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Cabazitaxel: 25 mg/m² i.v over 1 h on day 1. Cycles repeated ever 3 weeks
Other Name: Jevtana
- Overall Response Rate [ Time Frame: Disease evaluation at Week 6 ]
- Disease control rate [ Time Frame: Disease evaluation at Week 6 ]Disease control rate is defined as the proportion of patients with complete response plus partial response plus stable disease
- Progression Free Survival [ Time Frame: 1 year ]
- Overall Survival [ Time Frame: 1 year ]
- Toxicity profile [ Time Frame: Every 3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852578
|"Ag. Georgios" General Hospital of Chania|
|Chania, Crete, Greece|
|University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece|
|Heraklion, Crete, Greece|
|"IASO" General Hospital of Athens Athens, Greece|
|Air Forces Military Hospital of Athens Athens, Greece|
|"PAPAGEORGIOY" General Hospital of Thessaloniki|
|Principal Investigator:||Athanasio Kotsakis, MD||University Hospital of Herklion|