A randomized placebo-controlled phase II/III with celecoxib in patients with locally advanced or metastatic non-small cell lung cancer.
Completed
- Conditions
- iet-kleincellig longcarcinoom (NSCLC).
- Registration Number
- NL-OMON23374
- Lead Sponsor
- niversity Medical Center MaastrichtDepartment of Pulmonology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 540
Inclusion Criteria
1. Histological or cytological diagnosis of unresectable (stage III-b with or without pleuritis carcinomatosa) or disseminated (stage IV) NSCLC;
2. Age ≥ 18 years;
Exclusion Criteria
1. Other serious diseases, such as congestive heart failure NYHA class II-IV, established ischaemic heart disease or cerebrovascular disease, myocardial infarction within the last 12 months, peripheral arterial disease, uncontrolled hypertension, active peptic ulcer, active gastrointestinal bleeding, active infection or significant psychiatric illness;
2. Symptomatic brain metastases;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase II:<br /><br>To evaluate the antitumoral efficacy of celecoxib in combination with docetaxel/carboplatin in terms of tumour response (CR, PR versus SD, PD).<br /><br /><br>Phase III:<br /><br>To assess Overall Survival (OS).
- Secondary Outcome Measures
Name Time Method Phase II:<br /><br>1. To evaluate safety and tolerability of docetaxel/carboplatin with celecoxib as compared with docetaxel/carboplatin and placebo;<br /><br>2. To assess Quality of Life as measured by EORTC QLQ-C30 and QLQ-LC13;<br /><br>3. To estimate Progression-Free Survival (PFS);<br /><br>4. To assess Overall Survival (OS).<br><br /><br /><br>Phase III:<br /><br>1. To evaluate safety and tolerability of docetaxel/carboplatin with celecoxib as compared with docetaxel/carboplatin and placebo;<br /><br>2. To assess Quality of Life as measured by EORTC QLQ-C30 and QLQ-LC13;<br /><br>3. To assess Time To Progression (TTP).<br>