Weekly Versus 3-Weekly Docetaxel Plus Cisplatin for Advanced NSCLC

This study has been completed.
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT00319514
First received: April 28, 2006
Last updated: March 10, 2008
Last verified: March 2008
  Purpose

To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.


Condition Intervention Phase
Advanced Non-Small Cell Lung Cancer
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Two Different Schedules of Docetaxel Plus Cisplatin as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Objective response rate

Secondary Outcome Measures:
  • Progression-free survival
  • Overall survival
  • Safety

Estimated Enrollment: 78
Study Start Date: April 2004
Study Completion Date: October 2006
Detailed Description:

The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated with a significant incidence of severe neutropenia, often complicated by fever. Therefore, there has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. We designed this randomized phase II trial to evaluate the safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin given as first-line therapy in patients with advanced NSCLC.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically or cytologically proven non-small cell lung cancer
  • no prior chemotherapy or only adjuvant chemotherapy which had been completed >6 months before registration
  • ECOG performance status 0 to 2
  • measurable lesion(s)
  • normal marrow, hepatic and renal functions
  • provision of written informed consent

Exclusion Criteria:

  • active infection or severe comorbidities
  • history of anaphylaxis of any origin
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00319514

Locations
Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405 760
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319514     History of Changes
Other Study ID Numbers: GMO-LU-42
Study First Received: April 28, 2006
Last Updated: March 10, 2008
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
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 October 21, 2014