Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Phase II Trial of First-Line Therapy With Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Stage III or IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193453
• Other study ID #: SCRI LUN 92
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: October 11, 2012
• Start date: July 2005
• Est. completion date: December 2009

Study information

• Verified date: October 2012
• 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

This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Description:

Upon determination of eligibility all patients will receive:

• Docetaxel + Gemcitabine + Cetuximab

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

To be included in the study, you must meet the following criteria:

• 18 years of age or older

• Non-small cell lung cancer confirmed by biopsy

• Unresectable stage III or IV disease

• Measurable disease

• Must not have received any prior chemotherapy for lung cancer

• Able to perform activities of daily living without considerable assistance

• Adequate bone marrow, kidney, and liver function

• Signed informed consent

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

• History of serious heart disease within six months prior to study entry

• Prior treatment with agents that target the EGFR pathway

• History of any other uncontrolled or significant disease

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. You can then decide if you wish to participate.

Study Design

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:
• Gemcitabine
1000mg/m2 30min IV, Day 1 & 8
• Docetaxel
30mg/m2, 30min IV, day 1 & 8
• Cetuximab
100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 & 15, all subsequent cycles 250mg/m2 IV day 1, 8, & 15

Locations

Country	Name	City	State
United States	Northeast Alabama Regional Medical Center	Anniston	Alabama
United States	Graves-Gilbert Clinic	Bowling Green	Kentucky
United States	Consultants in Medical Oncology and Hematology	Drexel Hill	Pennsylvania
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Gainsville Hematology Oncology Associates	Gainesville	Florida
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Northeast Arkansas Clinic	Jonesboro	Arkansas
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Mercy Hospital	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spigel DR, Greco FA, Thompson DS, Webb C, Rubinsak J, Inhorn RC, Reeves J Jr, Vazquez ER, Lane CM, Burris HA 3rd, Hainsworth JD. Phase II study of cetuximab, docetaxel, and gemcitabine in patients with previously untreated advanced non-small-cell lung can — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Clinical Response Rate	Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment.	18 months	No
Secondary	Progression Free Survival (PFS)	Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause.	18 months	No
Secondary	Response Duration	The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.	18 months	No