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

NCT00193362 | Completed Phase 3

• 3 other identifiers: SCRI LUN 54B9E-MC-X338VNR-R47
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival.

Secondary Outcomes (4)

• Overall toxicity

• Overall response rate

• Time-to-progression

• Assess the quality of life

Interventions

Paclitaxel DRUG

Carboplatin DRUG

Gemcitabine DRUG

Vinorelbine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Eli Lilly and Company: collaborator
• GlaxoSmithKline: collaborator

Related 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 study of the Minnie Pearl Cancer Research Network. Clin Lung Cancer. 2007 Sep;8(8):483-7. doi: 10.3816/CLC.2007.n.032.

  PMID: 17922972 RESULT

Related Links

• Published article in Clinical Lung Cancer

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Paclitaxel; Carboplatin; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Anthony Greco, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: June 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: September 1, 2007
• Last Updated: July 28, 2010

Record last verified: 2010-07