Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Sarah Cannon Research Institute
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193453
First received: September 12, 2005
Last updated: October 11, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Gemcitabine Drug: Docetaxel Drug: Cetuximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sarah Cannon Research Institute:
Primary Outcome Measures:
- Overall Clinical Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Progression Free Survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]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.
- Response Duration [ Time Frame: 18 months ] [ Designated as safety issue: No ]The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
| Enrollment: | 69 |
| Study Start Date: | July 2005 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
|
Drug: Gemcitabine
1000mg/m2 30min IV, Day 1 & 8
Other Name: Gemzar
Drug: Docetaxel
30mg/m2, 30min IV, day 1 & 8
Other Name: Taxotere
Drug: Cetuximab
100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 & 15, all subsequent cycles 250mg/m2 IV day 1, 8, & 15
Other Name: Erbitux
|
Detailed Description:
Upon determination of eligibility all patients will receive:
- Docetaxel + Gemcitabine + Cetuximab
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193453
Locations
| United States, Alabama | |
| Northeast Alabama Regional Medical Center | |
| Anniston, Alabama, United States, 36207 | |
| United States, Arkansas | |
| Northeast Arkansas Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| Gainsville Hematology Oncology Associates | |
| Gainesville, Florida, United States, 32605 | |
| United States, Georgia | |
| Northeast Georgia Medical Center | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Kentucky | |
| Graves-Gilbert Clinic | |
| Bowling Green, Kentucky, United States, 42101 | |
| Consultants in Blood Disorders and Cancer | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Maine | |
| Mercy Hospital | |
| Portland, Maine, United States, 04101 | |
| United States, Pennsylvania | |
| Consultants in Medical Oncology and Hematology | |
| Drexel Hill, Pennsylvania, United States, 19026 | |
| United States, Tennessee | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
Sponsors and Collaborators
Sarah Cannon Research Institute
Bristol-Myers Squibb
Investigators
| Principal Investigator: | David R. Spigel, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193453 History of Changes |
| Other Study ID Numbers: | SCRI LUN 92 |
| Study First Received: | September 12, 2005 |
| Results First Received: | October 11, 2012 |
| Last Updated: | October 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sarah Cannon Research Institute:
|
Lung Cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Docetaxel Cetuximab |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013