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Completed

NCT Number: NCT00430651

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Crete, Heraklion, Crete, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

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

Other names: Taxotere

carboplatin

Drug

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

Primary outcomes

  1. Comparison of the overall survival between the two treatment groups

    Time frame: 1 year

Secondary outcomes

  1. 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)

  2. Evaluation and comparison of the toxicity between the two treatment groups

    Time frame: Toxicity assessment on each chemotherapy cycle

  3. Measurement and comparison of the health-related quality of life of patients on both treatment groups

    Time frame: Assessment every two cycles

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Collaborators

  • University Hospital of Crete

Registry information

Official study 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).

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 2, 2007
Registry last updated
Jan 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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