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

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: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 3

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hellenic Oncology Research Group
• Collaborators: University Hospital of Crete

Study record dates

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: Docetaxel; Non Small Cell Lung Cancer; 2nd line chemotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Carboplatin
• Other Study ID Numbers: CT/04.14