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Randomized Phase II Trial of Two Different Schedules of Docetaxel Plus Cisplatin as First-Line Therapy in Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Both
Advanced Non-Small Cell Lung Cancer

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Trial Information

Randomized Phase II Trial of Two Different Schedules of Docetaxel Plus Cisplatin as First-Line Therapy in Advanced Non-Small Cell Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Principal Investigator

Se Hoon Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gachon University Gil Medical Center, Incheon, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

GMO-LU-42

NCT ID:

NCT00319514

Start Date:

April 2004

Completion Date:

October 2006

Related Keywords:

  • Advanced Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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