Docetaxel in Non Small Cell Lung Cancer (NSCLC)

A Phase II Pilot Study of Combination of Irinotecan and Cisplatin in Docetaxel/Cisplatin-Responsive Advanced Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Tumour response rate
Survival at 1 year

Secondary Outcome Measures

Outcome Measure
Time to progression

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Iris CHAN, MD, Sanofi

Study record dates

Study Major Dates

• Study Start: May 1, 2005

Study Registration Dates

• First Submitted: December 6, 2005
• First Submitted That Met QC Criteria: December 6, 2005
• First Posted (Estimate): December 7, 2005

Study Record Updates

• Last Update Posted (Estimate): March 20, 2008
• Last Update Submitted That Met QC Criteria: March 18, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: XRP6976B_2503