Status:
COMPLETED
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Sanofi
Conditions:
Carcinoma, Squamous Cell
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00432315
Start Date
May 1 2001
End Date
October 1 2009
Last Update
September 14 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Vienna, Austria