Clinical trial NCT00379717 (phase 1/phase 2, status: unknown status)
Conditions: non-small-cell lung carcinoma
ICD codes: D02.20, D02.21, D02.22
Drugs: cisplatinum, docetaxel
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          1. Informed consent is required.

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

          3. Patients must have a stage III unresectable LA-NSCLC:

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

          5. Life expectancy of at least 12 weeks.

          6. ECOG performance status 0,1 or2.

          7. Weight loss ≤ 10% within the last 3 months.

          8. Laboratory requirements at entry:

             • Blood cell counts: i. Absolute neutrophils ≥ 2.0 x 109/L ii. Platelets ≥ 100 x 109/L
             iii. Haemoglobin ≥ 11 g/dl

             • Renal function: i. Serum creatinine < 1 x the upper limit of normal (UNL). ii. In
             case of borderline value of serum creatinine, the 24h creatinine clearance should be >
             60 ml/min.

             • Hepatic function: i. Serum bilirubin < 1 x UNL ii. ASAT and ALAT < 2.5 x UNL iii.
             alkaline phosphatase < 5 x UNL iv. Patient with ASAT and/or ALAT > 1.5 x UNL
             associated with alkaline phosphatase> 2.5 x UNL is 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, A1).

        Exclusion Criteria:

          1. Diagnosis of small cell lung cancer.

          2. Stage IIIB NSCLC, based on the presence of malignant pleural or pericardial effusion.

          3. Pregnant or lactating women.

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

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

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

          7. Prior radiotherapy for NSCLC.

          8. History of prior malignancy, 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.

          9. Symptomatic peripheral neuropathy Grade ≥ 2 except if due to trauma.

         10. Other serious concomitant illness or medical conditions:

         11. 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.

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

         13. Active infection requiring IV antibiotics.

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

         15. Superior vena cava syndrome contra-indicating hydration.

         16. Pre-existing pericardial effusion.

         17. Pre-existing symptomatic pleural effusion.

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

         19. Distant metastasis.

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

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

         22. Significant ophthalmologic abnormalities.

         23. Moderate to severe dermatitis.

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

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

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

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