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

Non-Small Cell Lung Cancer Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430651
• Other study ID #: CT/04.14
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2007
• Last updated: January 27, 2009
• Start date: July 2004
• Est. completion date: May 2008

Study information

• Verified date: January 2009
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Docetaxel
Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
• Carboplatin
Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15

Locations

Country	Name	City	State
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	"Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases	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	University Hospital of Crete	Heraklion	Crete
Greece	"Metaxa's" Anticancer Hospital of Pireaus	Piraeus
Greece	"Theagenion" Anticancer Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the overall survival between the two treatment groups		1 year	No
Secondary	Comparison of the objective response rates between the two treatment groups		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Evaluation and comparison of the toxicity between the two treatment groups		Toxicity assessment on each chemotherapy cycle	Yes
Secondary	Measurement and comparison of the health-related quality of life of patients on both treatment groups		Assessment every two cycles	No