Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193362
• Other study ID #: SCRI LUN 54
• Secondary ID: B9E-MC-X338VNR-R
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: July 27, 2010
• Start date: June 2004
• Est. completion date: September 2007

Study information

• Verified date: July 2010
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2007
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Patients must be available for treatment and followup.

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.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Paclitaxel

• Carboplatin

• Gemcitabine

• Vinorelbine

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Eli Lilly and Company, GlaxoSmithKline

References & Publications (1)

Greco FA, Spigel DR, Kuzur ME, Shipley D, Gray JR, Thompson DS, Burris HA, Yardley DA, Pati A, Webb CD, Gandhi JG, Hainsworth JD. Paclitaxel/Carboplatin/gemcitabine versus gemcitabine/vinorelbine in advanced non-small-cell lung cancer: a phase II/III stud — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival.
Secondary	Overall toxicity
Secondary	Overall response rate
Secondary	Time-to-progression
Secondary	Assess the quality of life