Clinical trial NCT00271323 (phase 2, status: terminated)
Conditions: non-small-cell lung carcinoma
ICD codes: D02.20, D02.21, D02.22
Drugs: docetaxel and cisplatin
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          1. Informed consent form obtained, signed and dated before specific protocol procedures.

          2. Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell
             carcinoma, large cell carcinoma or a combination of these)

          3. Patients must have a loco regionally advanced unresectable NSCLC;

               -  Stage IIIA with clinical multiple N2 nodes (preferably with histological or
                  cytological confirmation).

                    -  Patients with peripheral tumours of the lower lobe with contralateral upper
                       mediastinal nodes at station N2 are excluded·

               -  Stage IIIB T4 or N3.

                    -  In the T4 category, patients with pleural or pericardial effusion and
                       multiple nodules in the same lobe are excluded.

                    -  Patients with T4 disease secondary to extensive and massive involvement of
                       the great vessels are excluded.Patients should be excluded when the expected
                       risk of pulmonary toxicity is likely to be high, e.g. V20 in excess of 35%.

          4. Males or females aged between 18 and 75 years.

          5. Life expectancy of at least 12 weeks.

          6. WHO performance status 0 or 1.

          7. Weight loss <=10% within the last 3 months.

          8. Laboratory requirements at entry (within 7 days before randomization):

               -  Blood cell counts:

                    -  Absolute neutrophils >= 2.0 x 10^9/L

                    -  Platelets >= 100 x 10^9/L

                    -  Hemoglobin >= 10 g/dl

               -  Renal function:

                    -  Serum creatinine <=1 x the upper limit of normal (UNL). In case of
                       borderline value of serum creatinine, the 24h creatinine clearance should be
                       >= 60 mL/min.

               -  Hepatic function:

                    -  Serum bilirubin <= 1 x UNL

                    -  ASAT and ALAT <= 2.5 x UNL

                    -  Alkaline phosphatase <= 5 x UNL Patients with ASAT and/or ALAT > 1.5 x UNL
                       associated with alkaline phosphatase> 2.5 x UNL are not eligible for the
                       study.

          9. Lung function tests at entry:

               -  FEV1: >= 50 % x Normal value

               -  DLCO: >= 50 % x Normal value

         10. Adequate cardiac function.

         11. Patient with either measurable and/or non-measurable lesion (according to RECIST
             criteria).

        Exclusion Criteria:

          1. Diagnosis of small cell lung cancer.

          2. Pregnant or lactating women.

          3. Patients (male or female) with reproductive potential not implementing adequate
             contraceptive measures.

          4. Prior systemic chemotherapy, immunotherapy, or biological therapy including
             neoadjuvant or adjuvant treatment for NSCLC.

          5. Prior surgery for NSCLC, if less than 5 years from study.

          6. Prior radiotherapy for NSCLC.

          7. History of prior malignancies, except for cured non-melanoma skin cancer, curatively
             treated in-situ carcinoma of the cervix or other cancer curatively treated and with no
             evidence of disease for at least five years.

          8. Symptomatic peripheral neuropathy Grade >= 2 except if due to trauma.

          9. Other serious concomitant illness or medical conditions:

               -  Congestive heart failure or angina pectoris except if it is medically controlled.
                  Previous history of myocardial infarction within 1 year from study entry,
                  uncontrolled hypertension or arrhythmias.

               -  History of significant neurological or psychiatric disorders including dementia
                  or seizures.

               -  Active infection requiring IV antibiotics.

               -  Active ulcer, unstable diabetes mellitus or other contra-indication to
                  corticosteroid therapy.

               -  Superior vena cava syndrome contra-indicating hydration.

               -  Preexisting pericardial effusion.

               -  Preexisting symptomatic pleural effusion.

         10. Significant gastrointestinal abnormalities, including requirement for intravenous
             nutrition, active peptic ulcer disease, prior surgical procedures affecting
             absorption.

         11. Distant metastasis.

         12. Concurrent treatment with any other experimental anti-cancer drugs.

         13. Concomitant or within 4-week period administration of any other experimental drug
             under investigation.

         14. Significant ophthalmologic abnormalities.

         15. Moderate to severe dermatitis.

         16. Hypersensitivity to docetaxel, cisplatin, or any of its excipients.

         17. Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.

         18. Mental condition rendering the patient unable to understand the nature, scope, and
             possible consequences of the study.

         19. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to
             return for follow-up visits, and not likely to complete the study.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.