Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

January 27, 2009 updated by: Hellenic Oncology Research Group

Multicenter Randomized Phase III Study Comparing Docetaxel With Carboplatin Versus Docetaxel Single Agent as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (NSCLC).

This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Dep of Medical Oncology
      • Athens, Greece
        • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
      • Athens, Greece
        • 401 Military Hospital, Medical Oncology Unit
      • Athens, Greece
        • Air Forces Military Hospital, Dep of Medical Oncology
      • Athens, Greece
        • Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
      • Athens, Greece
        • "IASO" General Hospital of Athnes, Dep of Medical Oncology
      • Athens, Greece
        • "Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
      • Piraeus, Greece
        • "Metaxa's" Anticancer Hospital of Pireaus
      • Thessaloniki, Greece
        • "Theagenion" Anticancer Hospital of Thessaloniki
    • Crete
      • Heraklion, Crete, Greece, 71110
        • University Hospital of Crete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed NSCLC.
  • ECOG Performance Status 0-2.
  • No previous treatment with Docetaxel.
  • Measurable Disease.
  • Brain metastases that have been treated with radiotherapy should be stable and asymptomatic.
  • Adequate liver kidney and bone marrow function.
  • Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

  • Active cardiac disease: unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Women who are pregnant or lactating.
  • Unknown HIV, chronic hepatitis B or chronic hepatitis C infections.
  • Serious neurologic or psychiatric disease.
  • Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix.
  • Active uncontrolled infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Docetaxel + Carboplatin
Drug: Docetaxel
Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
Other Names:
  • Taxotere
Drug: Carboplatin
Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15
Experimental: 2
Docetaxel
Drug: Docetaxel
Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the overall survival between the two treatment groups
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of the objective response rates between the two treatment groups
Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Evaluation and comparison of the toxicity between the two treatment groups
Time Frame: Toxicity assessment on each chemotherapy cycle
Toxicity assessment on each chemotherapy cycle
Measurement and comparison of the health-related quality of life of patients on both treatment groups
Time Frame: Assessment every two cycles
Assessment every two cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/04.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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