Status:
COMPLETED
Pulmonart: Docetaxel - Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Sanofi
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Primary Objective: * To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolid...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
- Patients must have a locoregionally advanced unresectable NSCLC
- Stage IIIA with multiple level clinical N2 nodes (preferably with histological or cytological confirmation).
- Patients with peripheral tumours of the lower lobe with contralateral upper mediastinal nodes at station N2 are excluded
- Stage IIIB T4 or N3
- In the T4 category, patients with pleural or pericardial effusion and multiple nodules in the same lobe are excluded.
- Patients with T4 disease secondary to extensive and massive involvement of the great vessels are excluded.
- Patients should be excluded when the expected risk of pulmonary toxicity is likely to be high, e.g. V20 in excess of 35%.
- Life expectancy of at least 12 weeks.
- WHO performance status 0 or 1.
- Weight loss ≤ 10% within the last 3 months.
- Laboratory requirements at entry (within 7 days before randomization):
- Blood cell counts:
- Absolute neutrophils ≥ 2.0 x 10\^9/L
- Platelets ≥ 100 x 10\^9/L
- Hemoglobin ≥ 10 g/dl
- Renal function:
- \_Serum creatinine ≤1 x the upper limit of normal (UNL). In case of borderline value of serum creatinine, the 24h creatinine clearance should be ≥ 60 mL/min
- Hepatic functions:
- Serum bilirubin ≤ 1 x UNL
- ASAT and ALAT ≤ 2.5 x UNL
- Alkaline phosphatase ≤ 5 x UNL.
- Patients with ASAT and/or ALAT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL are not eligible for the study.
- Lung function tests at entry:
- FEV1: ≥ 50 % x Normal value
- DLco: ≥ 50 % x Normal value.
- Adequate cardiac function.
- Patient with either measurable and/or non-measurable lesion (according to RECIST criteria).
- Exclusion criteria:
- Diagnosis of small cell lung cancer
- Pregnant or lactating women
- Patients (male or female) with reproductive potential not implementing adequate contraceptive measures
- Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC
- Prior surgery for NSCLC, if less than 5 years from study
- Prior radiotherapy for NSCLC
- History of prior malignancies, 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.
- Symptomatic peripheral neuropathy Grade ≥ 2 except if due to trauma.
- Other serious concomitant illness of medical conditions:
- 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.
- History of significant neurologic or psychiatric disorders including dementia or seizures.
- Active infection requiring IV antibiotics.
- Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy.
- Superior vena cava syndrome contra-indicating hydration.
- Preexisting pericardial effusion.
- Preexisting symptomatic pleural effusion.
- Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
- Distant metastasis.
- Concurrent treatment with any other experimental anti-cancer drugs.
- Concomitant or within 4-week period administration of any other experimental drug under investigation.
- Significant ophthalmologic abnormalities.
- Moderate to severe dermatitis.
- Hypersensitivity to docetaxel or any of its excipients.
- Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
- Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00174772
Start Date
March 1 2004
End Date
February 1 2009
Last Update
February 17 2010
Active Locations (8)
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1
Sanofi-Aventis Administrative Office
Diegem, Belgium
2
Sanofi-Aventis Administrative Office
Helsinki, Finland
3
Sanofi-Aventis Administrative Office
Paris, France
4
Sanofi-Aventis Administrative Office
Milan, Italy