Carcinoma, Non-small-cell Lung
Conditions
Keywords
NSCLC, non-small-cell lung cancer
Brief summary
Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines.
Detailed description
Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines. Secondary objective is * To evaluate pathological response determined by histological work up of the surgical specimens according to TNM stages. * To evaluate the metabolic response determined by PET analysis. * To assess overall survival (OS) (median survival time and percentage of 1-year survival). OS is defined as time elapsed from the date of patient inclusion until recorded date of death. * To characterize and quantify toxic effects of the scheduled therapy. Safety profile and tolerability will be assessed by recording adverse events, clinically significant laboratory abnormalities, physical examination and vital signs. Toxicities will be evaluated according to the NCI-CTC Toxicity Criteria and adverse events which are not reported in NCI-CTC will be graded as mild, moderate, severe or life-threatening. All patients who received any of the scheduled therapy will be included in the overall toxicity analysis. * To evaluate the immunological response determined by regulatory T-cells and immune activation markers, to define chemoresistance by pharmacogenomic testing.
Interventions
DRUGDocetaxel
75mg/m², day 1,22
DRUGoxaliplatin
40mg/m², d1,2,22,23
DRUGcetuximab
400mg/m² (day1), 250mg/m² (day 8,15,22,29,36)
PROCEDUREsurgery
28 days after end of induction chemotherapy
Sponsors
Merck Sharp & Dohme LLC
Sanofi
TAKO - Tiroler Arbeitskreis Onkologie
Wolfgang Hilbe
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Histology and staging of the disease * Histological confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC. * Anatomically and functionally resectable NSCLC stage IB (T2N0) stage II (T1-2 N1, T3 N0) or stage IIIA (T3 N1) (see TAKO guidelines 2006, www.tako.or.at) * Measurable disease according to RECIST criteria General conditions * 18-80 years. * WHO 0-2; life expectancy of more than 3 months * Effective contraception for both male and female patients if the risk of conception exists * Adequate respiratory function, sufficient for necessary surgical treatment * Adequate hematological function (Hb \> 10 g/dl, ANC \> 2.0 x 10 9/L, platelets \> 100 x 10 9/L). * Adequate renal and hepatic functions: total bilirubin within normal limits, serum creatinine within normal limits, in case of limit value the creatinine clearance should be \> 60 ml/min, ASAT and ALAT \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL. Initial work-up * Complete initial work-up within three weeks prior to first infusion includes chest CT scan, abdominal CT-scan, brain CT scan if indicated, PET-scan, bronchoscopy and mediastinoscopy, pulmonary function. Within 7 days prior to inclusion laboratory investigations and biological work up. * Signed initial consent prior to protocol specific procedures.
Exclusion criteria
Diagnosis * Evidence of brain metastases or other distant metastasis equivalent to stage IV disease * History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years * Other serious concomitant illness or medical condition: * Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia * History of significant neurological or psychiatric disorders, including dementia or seizure * Active infection requiring i.v. antibiotics * Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy * Current peripheral neuropathy WHO grade \> 2 Prior or concurrent therapy * Prior chemotherapy or immunotherapy for NSCLC * Prior surgery or radiotherapy for NSCLC * Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy * Concurrent continuous treatment with systemic steroids for antiemetic use, intermittent application is allowed General conditions * Pregnant (absence to be confirmed by ß-HCG-test) or lactating patients * Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements * Participation in other clinical trials with experimental agents or non approved medical procedures during study and within 30 days prior to study entry * Psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate (complete plus partial response) according to RECIST guidelines | June 2011 |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic response | June 2011 |
| Immunological response | June 2011 |
| Pathological response | June 2011 |
| Safety profile and tolerability | June 2011 |
| overall response rate (complete plus partial response) according to RECIST guidelines | June 2011 |
| Overall survival | June 2011 |
Countries
Austria
Outcome results
None listed