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

This study has been completed.
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00430651
First received: February 1, 2007
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Docetaxel
Drug: Carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Comparison of the overall survival between the two treatment groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the objective response rates between the two treatment groups [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
  • Evaluation and comparison of the toxicity between the two treatment groups [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Measurement and comparison of the health-related quality of life of patients on both treatment groups [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: July 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Docetaxel + Carboplatin
Drug: Docetaxel
Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
Other Name: Taxotere
Drug: Carboplatin
Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15
Other Name: Carboplatin
Experimental: 2
Docetaxel
Drug: Docetaxel
Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
Other Name: Taxotere

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430651

Locations
Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens, Greece
"Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
Athens, Greece
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
401 Military Hospital, Medical Oncology Unit
Athens, Greece
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece
"Metaxa's" Anticancer Hospital of Pireaus
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided

Responsible Party: V.Georgoulias, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00430651     History of Changes
Other Study ID Numbers: CT/04.14
Study First Received: February 1, 2007
Last Updated: January 27, 2009
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Non Small Cell Lung Cancer
2nd line chemotherapy
Docetaxel

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014