Bortezomib in Combination With Gemcitabine and Cisplatin in Advanced or Metastatic Non-Small Cell Lung Cancer
NCT01633645 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2015-09-28
Summary
The primary objective of this study is to establish the objective response rate (complete response + partial response) following treatment with VELCADE in combination with cisplatin plus gemcitabine in patients with locally advanced (Stage IIIb) or metastatic (stage IV non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for advanced disease
Conditions
- Non Small Cell Lung Cancer
- Metastatic
Interventions
- DRUG
-
Velcade
- DRUG
-
Gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-days treatment cycle for a maximum of 8 cycles
- DRUG
-
Cisplatin 70 mg/m2 on day 1 of a 21-days treatment cycle for a maximum of 8 cycles
Sponsors & Collaborators
-
University Hospital of Crete
lead OTHER
Principal Investigators
-
Vassilis Georgoulias, MD · University Hospital of Heraklion
-
Sofia Aggelaki, MD · University Hospital of Heraklion
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2013-04-30
- Completion
- 2013-04-30
Countries
- Greece
Study Locations
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