Docetaxel in Non Small Cell Lung Cancer (NSCLC)

NCT00263016 | Terminated Phase 2

• 1 other identifier: XRP6976B_2503
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Tumour response rate

• Survival at 1 year

Secondary Outcomes (1)

• Time to progression

Interventions

Docetaxel DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-aventis

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Iris CHAN, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: May 1, 2005
• Last Updated: March 20, 2008

Record last verified: 2008-03

Locations

HK (1)