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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)

NCT00684099

Non Small Cell Lung Cancer

COMPLETED PHASE1/PHASE2

Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

NCT00441922

Non Small Cell Lung Cancer

COMPLETED PHASE3

Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)

NCT00431613

Non Small Cell Lung Cancer

TERMINATED PHASE2

Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

NCT00442026

Non-small-cell Lung Cancer

TERMINATED PHASE3

Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

NCT00022022

Lung Cancer

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Docetaxel + Carboplatin

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

2

Docetaxel

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docetaxel

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

Intervention Type DRUG

Carboplatin

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Taxotere

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No