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

Phase 3

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Docetaxel; Drug: Carboplatin

• Registration Number: NCT00430651
• Lead Sponsor: Hellenic Oncology Research Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-27
• Last Update Posted: 2009-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	Docetaxel + Carboplatin
1	Carboplatin	Docetaxel + Carboplatin
2	Docetaxel	Docetaxel

Primary Outcome Measures

Name	Time	Method
Comparison of the overall survival between the two treatment groups	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

University Hospital of Crete; 🇬🇷 Heraklion, Crete, Greece

"Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases; 🇬🇷 Athens, Greece

"Theagenion" Anticancer Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Air Forces Military Hospital, Dep of Medical Oncology; 🇬🇷 Athens, Greece

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases; 🇬🇷 Athens, Greece

401 Military Hospital, Medical Oncology Unit; 🇬🇷 Athens, Greece

"Metaxa's" Anticancer Hospital of Pireaus; 🇬🇷 Piraeus, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

"IASO" General Hospital of Athnes, Dep of Medical Oncology; 🇬🇷 Athens, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece