Clinical trial NCT00432315 (phase 2, status: completed)
Conditions: carcinoma, squamous cell
ICD codes: C44.520, C44.92, C44.02, C44.321, C44.521, C44.82, C44.42
Drugs: docetaxel + cddp, docetaxel + cddp
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          1. Histology and staging of the disease

               -  Histologically or cytologically confirmed NSCLC; histology may include: large
                  cell, squamous cell or adenocarcinoma but no SCLC

               -  Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2
                  or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3)

               -  Measurable disease (bidimensionally or unidimensionally according to WHO
                  criteria)

          2. General conditions

               -  Karnofsky Status > 70, if age > 70 years → PS > 70

               -  Adequate hematological function (Hb > 10 g/dl, ANC > 2.0 x 109/L, platelets > 100
                  x 109/L)

               -  Adequate renal and hepatic functions: total bilirubin < 1 x upper normal limit
                  (UNL), serum creatinine < 1 x UNL, 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.

        Exclusion Criteria:

          1. 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 neurologic or psychiatric disorders, including
                       dementia or seizure

                    -  Active infection requiring i.v. Antibiotics

                    -  Active ulcer, unstable diabetes mellitus or other contraindications to
                       corticotherapy

               -  Hepatic function abnormality: ASAT and/or ALAT > 1.5 x UNL associated with
                  alkaline phosphatase > 2.5 x UNL

               -  Current peripheral neuropathy WHO grade > 2

          2. Prior or concurrent therapy

               -  Prior chemotherapy or immunotherapy for NSCLC, including neoadjuvant or adjuvant
                  treatment

               -  Prior surgery or radiotherapy for NSCLC

               -  Concurrent treatment with other experimental drugs, unapproved medical procedures
                  or other anticancer therapy

          3. General conditions

               -  Pregnant or lactating patients

               -  Patients (M/F) with reproductive potential not implementing adequate
                  contraceptive measurements

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