Docetaxel in Non Small Cell Lung Cancer (NSCLC)
Study Details
Study Description
Brief Summary
Primary Objective:
- To compare the tumour response rate of combination chemotherapy irinotecan/cisplatin (IC) versus docetaxel/cisplatin (DC) in advanced NSCLC patients who responded to 3 courses of docetaxel/cisplatin.
Secondary Objectives :
-
To compare the time to progression after chemotherapy treatment between the IC and DC arms of treatment.
-
To compare the toxicity profile of the IC and DC arms of treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- Tumour response rate []
- Survival at 1 year []
Secondary Outcome Measures
- Time to progression []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically or cytologically proven non-small cell lung carcinoma at first diagnosis.
-
Stage IIIB or IV disease.
-
Tumour considered unresectable.
-
Performance status Karnofsky index > 60% or WHO performance status < or = 1.
-
Previous therapy
-
Chemotherapy: None.
-
Previous radiation therapy: prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal.
-
Laboratory requirements:
-
Hematology:
-
Neutrophils ≥ 2.0 10^9/l,
-
Platelets ≥ 100 10^9/l,
-
Hemoglobin ≥ 10 g/dl.
-
Hepatic function:Total bilirubin < 1 Upper Normal Limit (UNL), AST (SGOT) and ALT (SGPT) < 2.5 UNL,Alkaline phosphatase < 5 UNL ; except in presence of only bone metastasis and in absence of any liver disorders. Patients with AST and/or ALT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.
-
Renal function: Creatinine < 140 µmol/l (1.6 mg/dl) ; if limit values, the calculated creatinine clearance should be > 60 ml/min.
Exclusion Criteria:
-
Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation.
-
Known clinical brain or leptomeningeal involvement.
-
Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by National Cancer Institute criteria.
-
Other serious illness or medical condition:
-
Congestive heart failure or unstable angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrhythmias.
-
History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
-
Active uncontrolled infection.
-
Peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids.
-
Past or current history of neoplasm other than non-small cell lung cancer, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix.
-
Concurrent treatment with prednisone (or equivalent) except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or unless chronic treatment (initiated > 6 months prior to study entry) at low dose (< 20 mg methylprednisolone or equivalent).
-
Definite contraindications for the use of corticosteroids.
-
Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.
-
Concurrent treatment with any other anti-cancer therapy.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-aventis | Hong Kong | Hong Kong |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Iris CHAN, MD, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XRP6976B_2503