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Docetaxel in Non Small Cell Lung Cancer (NSCLC)

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00263016
First received: December 6, 2005
Last updated: March 18, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Pilot Study of Combination of Irinotecan and Cisplatin in Docetaxel/Cisplatin-Responsive Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Tumour response rate
  • Survival at 1 year

Secondary Outcome Measures:
  • Time to progression

Estimated Enrollment: 50
Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263016

Locations
Hong Kong
Sanofi-aventis
Hong Kong, Hong Kong
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Iris CHAN, MD Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00263016     History of Changes
Other Study ID Numbers: XRP6976B_2503
Study First Received: December 6, 2005
Last Updated: March 18, 2008
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014