Docetaxel in Non Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective:

• To assess the response rate to induction therapy with docetaxel/CDDP.

Secondary objectives:

To assess

• Resectability after induction therapy

• Time to progression

• Overall survival

• Safety profile

• Quality of Life

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cisplatin; Docetaxel

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.