Docetaxel in Non Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00263016

Last Updated: 2008-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Docetaxel

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Iris CHAN, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-aventis

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

XRP6976B_2503

Identifier Type: -

Identifier Source: org_study_id