Clinical trial NCT00193453: Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Upon determination of eligibility all patients will receive:

* Docetaxel + Gemcitabine + Cetuximab

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Clinical Response Rate
timeFrame: 18 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 18 months
measure: Response Duration
timeFrame: 18 months
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Northeast Alabama Regional Medical Center
state: Alabama
city: Jonesboro
country: United States
facility: Northeast Arkansas Clinic
state: Arkansas
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Gainesville
country: United States
facility: Gainsville Hematology Oncology Associates
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Portland
country: United States
facility: Mercy Hospital
state: Maine
city: Drexel Hill
country: United States
facility: Consultants in Medical Oncology and Hematology
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R. Spigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 cancer. Clin Lung Cancer. 2010 May;11(3):198-203. doi: 10.3816/CLC.2010.n.026.