Clinical trial NCT00430651: Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
2nd line chemotherapy
Docetaxel
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2007-02-02
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the overall survival between the two treatment groups
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of the objective response rates between the two treatment groups
timeFrame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
measure: Evaluation and comparison of the toxicity between the two treatment groups
timeFrame: Toxicity assessment on each chemotherapy cycle
measure: Measurement and comparison of the health-related quality of life of patients on both treatment groups
timeFrame: Assessment every two cycles
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athnes, Dep of Medical Oncology
city: Athens
country: Greece
facility: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: "Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
city: Athens
country: Greece
facility: 401 Military Hospital, Medical Oncology Unit
city: Athens
country: Greece
facility: Air Forces Military Hospital, Dep of Medical Oncology
city: Athens
country: Greece
facility: Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
city: Piraeus
country: Greece
facility: "Metaxa's" Anticancer Hospital of Pireaus
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki
Study officials:
affiliation: University Hospital of Crete, Dep of Medical Oncology
name: Vassilis Georgoulias, MD
role: PRINCIPAL_INVESTIGATOR
References: