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Clinical Trials/NCT00193362
NCT00193362
Completed
Phase 3

Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer

SCRI Development Innovations, LLC0 sites200 target enrollmentJune 2004
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ConditionsLung Cancer
DrugsPaclitaxelCarboplatinGemcitabineVinorelbine

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
SCRI Development Innovations, LLC
Enrollment
200
Primary Endpoint
Overall survival.
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to compare the effectiveness of the three-drug combination paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and vinorelbine in patients with advanced Non-Small Cell Lung Cancer

Detailed Description

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * Paclitaxel + Carboplatin + Gemcitabine * Gemcitabine + Vinorelbine For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
September 2007
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •To be included in this study, you must meet the following criteria:
  • •Non-small cell bronchogenic carcinoma
  • •Newly diagnosed unresectable stage IIIB or stage IV disease
  • •Patients with stage IIIB disease should be ineligible for combined therapy
  • •Patients must have measurable lesion definable by X-ray or CT scan.
  • •No prior antineoplastic chemotherapy for lung cancer prior to study entry
  • •Age \> 18 years
  • •Able to perform activities of daily living with minimal assistance
  • •Adequate bone marrow, liver and kidney function
  • •Written informed consent must be obtained prior to study entry

Exclusion Criteria

  • •You cannot participate in this study if any of the following apply to you:
  • •Female patient pregnant or lactating
  • •History of heart disease
  • •Serious active infection at the time of treatment
  • •Other serious underlying medical condition
  • •Brain metastasis
  • •Patients without measurable disease
  • •Uncontrolled diabetes mellitus defined as random blood sugar \> 250mg/dL
  • •Dementia or significantly altered mental status
  • •Significant peripheral neuropathy by history or physical examination.

Outcomes

Primary Outcomes

Overall survival.

Secondary Outcomes

  • Overall toxicity
  • Overall response rate
  • Time-to-progression
  • Assess the quality of life

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