Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Recruitment & Eligibility

Inclusion Criteria

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)
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

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
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
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.

Study & Design

Arm && Interventions

Group	Intervention	Description
1	docetaxel + CDDP	Resectable NSCLC
2	docetaxel + CDDP	Unresectable NSCSC

Primary Outcome Measures

Name	Time	Method
To assess the response rate to induction therapy with docetaxel in combination with CDDP	every 3 months until tumour progression and thereafter every 6 months until death

Secondary Outcome Measures

Name	Time	Method
Resectability after induction therapy	every 3 months until tumour progression and thereafter every 6 months until death
Time to progression	every 3 months until tumour progression and thereafter every 6 months until death
Overall survival	every 3 months until tumour progression and thereafter every 6 months until death
Safety profile	throughout the study
Quality of life	every 3 months until tumour progression and thereafter every 6 months until death

Recruitment & Eligibility