A Phase II, Open-Label Trial of Bortezomib (Velcade®) in Combination with Gemcitabine and Cisplatin in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
- Conditions
- First Line treatment for Locally Advanced or Metastatic Non-Small Cell Lung Cancer.MedDRA version: 8.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer
- Registration Number
- EUCTR2006-004963-68-GR
- Lead Sponsor
- Prof Vassilis Georgoulias
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Patients with locally advanced Stage III? (not amenable to curative treatment) or metastatic (Stage IV) NSCLC who have not received prior systemic anti-neoplastic therapy (one additional prior line is allowed if given as neo-adjuvant or adjuvant therapy to tumor resection) will be enrolled in the study. The patient population comprises of men or women, 18 years of age or older. NSCLC must be histologically or cytologically confirmed. Additional inclusion criteria include: measurable disease per RECIST criteria and ECOG performance status score of 0 to 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria for this study include: presence of peripheral neuropathy of Grade 2 or greater intensity; significant weight loss (documented =10% body weight in the 6 weeks before randomization); inadequate organ function at the screening visit as defined in the protocol; cardiac disease as defined in the protocol;; active systemic infection requiring treatment; active second malignancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method