NCT00430651CompletedPhase 3
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).
Hellenic Oncology Research Group10 sites in 1 country135 target enrollmentStarted: July 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 135
- Locations
- 10
- Primary Endpoint
- Comparison of the overall survival between the two treatment groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed NSCLC.
- •ECOG Performance Status 0-
- •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.
Arms & Interventions
1
Experimental
Docetaxel + Carboplatin
Intervention: Docetaxel (Drug)
1
Experimental
Docetaxel + Carboplatin
Intervention: Carboplatin (Drug)
2
Experimental
Docetaxel
Intervention: Docetaxel (Drug)
Outcomes
Primary Outcomes
Comparison of the overall survival between the two treatment groups
Time Frame: 1 year
Secondary Outcomes
- 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)
Investigators
Study Sites (10)
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