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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Docetaxel
Carboplatin
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, 2nd line chemotherapy, Docetaxel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Docetaxel + Carboplatin

Docetaxel

Outcomes

Primary Outcome Measures

Comparison of the overall survival between the two treatment groups

Secondary Outcome Measures

Comparison of the objective response rates between the two treatment groups
Evaluation and comparison of the toxicity between the two treatment groups
Measurement and comparison of the health-related quality of life of patients on both treatment groups

Full Information

First Posted
February 1, 2007
Last Updated
January 27, 2009
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00430651
Brief Title
Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
Official Title
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).
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non Small Cell Lung Cancer, 2nd line chemotherapy, Docetaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Docetaxel + Carboplatin
Arm Title
2
Arm Type
Experimental
Arm Description
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15
Primary Outcome Measure Information:
Title
Comparison of the overall survival between the two treatment groups
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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)
Title
Evaluation and comparison of the toxicity between the two treatment groups
Time Frame
Toxicity assessment on each chemotherapy cycle
Title
Measurement and comparison of the health-related quality of life of patients on both treatment groups
Time Frame
Assessment every two cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vassilis Georgoulias, MD
Organizational Affiliation
University Hospital of Crete, Dep of Medical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athnes, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
"Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
401 Military Hospital, Medical Oncology Unit
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
"Metaxa's" Anticancer Hospital of Pireaus
City
Piraeus
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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