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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00430651

Enrollment

135

Registered

2007-02-02

Start date

2004-07-31

Completion date

2008-05-31

Last updated

2009-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, 2nd line chemotherapy, Docetaxel

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.

Interventions

DRUGCarboplatin

Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15

DRUGDocetaxel

Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Comparison of the overall survival between the two treatment groups	1 year

Secondary

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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026