extensive disease small-cell lung cancer (ED-SCLC)
Conditions
Interventions
Trade Name: Celebrex
Product Name: NA
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: celekoxib
Sponsors
UNIVERSITY CLINIC GOLNIK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population will consist of patients aged 18 years and older with chemonaive, cytologicaly/histologicaly proven ED-SCLC. 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: •Patients not understanding the disease and no signed written informed consent •Life expectancy less than 12 weeks •Other malignant disease except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, or less than 3 years after treatment of other malignant disease •Known hypersensitivity to acetylsalicylic acid, selective COX-2 inhibitors, other NSAIDs, or sulfonamides •active ulcer disease •ECOG PS more than 2 •One or more of the following cardiovascular conditions within the past 6 months: - Myocardial infarction - Cerebrovascular accident or transient ischemic attack - Pulmonary embolism - Unstable angina - Symptomatic congestive heart failure or congestive heart failure NYHA III-IV - Uncontrolled cardiac arrhythmia - Uncontrolled hypertension - Symptomatic carotid artery or peripheral vascular disease - Deep vein thrombosis - Other significant thromboembolic events •Abnormal organ as defined below: -severe hepatic dysfunction (AST/ALT> 5 x ULN, bilirubin > 4xUNL, serum albumine < g/L -estimated creatinine clearance < 30 mL/min •Other contraindication for PE/CEV/CAV treatment •Pregnancy or breastfeeding •Concomitant fluconazol treatment •Galactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the efficacy of combination of celecoxib and standard chemotherapy as first line treatment for ED-SCLC; Secondary Objective: •Validate the use of the progression free survival rate (PFSR) at 20 weeks as primary endpoint for the design of SCLC phase II trials •Perform an explorative translational research program, looking at the use of serum CRP, tissue COX-2 expression, urinary PGE-M in the assessment of response and survival ;Primary end point(s): progression-free survival (PFS);Timepoint(s) of evaluation of this end point: Patient will have a CT scan to define response/progression according to modified RECIST criteria after 6-9 weeks of chemotherapy treatment, at the end of chemotherapy treatment and every 2 months during celecoxib maintenance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Overall response rate (ORR) •Progression free survival rate at 20 weeks (PFSR-20) •Overall survival (OS) •Safety and tolerability of celecoxib in combination with standard chemotherapy according to CTCAE version 4.0. •COX-2 protein expression (IHC) and gene copy number (PCR) in primary tumor, CRP determination in serum and urinary PGE-M for the assessment of response rate and survival. ; Timepoint(s) of evaluation of this end point: Patient will have a CT scan to define response/progression according to modified RECIST criteria after 6-9 weeks of chemotherapy treatment, at the end of chemotherapy treatment and every 2 months during celecoxib maintenance. Treatment side effects will be assessed separately at every control visit. COX-2 expression will be determined prior treatment initiation, CRP will be determined at every visit and PGE-M will be determined at the begining of the treatment, after 1.cycle of chemotherapy and at the time of progression. | — |
Countries
Slovenia
Contacts
Public ContactRAZISKOVALNI ODDELEK
UNIVERSITY CLINIC GOLNIK
Outcome results
None listed