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

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ClinicalTrials.gov Identifier: NCT00193453
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 13, 2012
Last Update Posted : November 13, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: Gemcitabine
Drug: Docetaxel
Drug: Cetuximab
Enrollment 69
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 69
Completed 21
Not Completed 48
Arm/Group Title Intervention
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  26.1%
>=65 years
51
  73.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants
68  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants
Female
21
  30.4%
Male
48
  69.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 69 participants
69
1.Primary Outcome
Title Overall Clinical Response Rate
Hide Description 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.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.
Arm/Group Title Intervention
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 65
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
17
(9 to 29)
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were assessed for progression-free survival.
Arm/Group Title Intervention
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 69
Median (95% Confidence Interval)
Unit of Measure: Months
4.0
(2.7 to 5.9)
3.Secondary Outcome
Title Response Duration
Hide Description The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.
Arm/Group Title Intervention
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 65
Median (95% Confidence Interval)
Unit of Measure: Months
7.0
(2.5 to 8.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention
Hide Arm/Group Description 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).
All-Cause Mortality
Intervention
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention
Affected / at Risk (%)
Total   43/69 (62.32%) 
Blood and lymphatic system disorders   
Edema  1  1/69 (1.45%) 
Hemorrhage, GI – Peritoneal cavity  1  1/69 (1.45%) 
Neutrophils  1  1/69 (1.45%) 
Cardiac disorders   
Atrial fibrillation  1  4/69 (5.80%) 
Cardiac Arrhythmia – Other (Abnormal EKG)  1  1/69 (1.45%) 
Cardiac Arrythmia (NOS)  1  1/69 (1.45%) 
Cardiac ischemia/infarction  1  4/69 (5.80%) 
Cardiopulmonary arrest  1  1/69 (1.45%) 
Supraventricular arrhythmia NOS  1  1/69 (1.45%) 
Gastrointestinal disorders   
Dehydration  1  3/69 (4.35%) 
Diarrhea  1  2/69 (2.90%) 
Vomiting  1  2/69 (2.90%) 
General disorders   
Death not associated with CTCAE term – Disease Progression NOS  1  6/69 (8.70%) 
Fatigue  1  2/69 (2.90%) 
Fever  1  1/69 (1.45%) 
Immune system disorders   
Allergic reaction  1  3/69 (4.35%) 
Infections and infestations   
Infection - Other (Cellulitis)  1  1/69 (1.45%) 
Infection - Other (Pneumonia)  1  5/69 (7.25%) 
Renal and urinary disorders   
Renal failure  1  2/69 (2.90%) 
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Distress Syndrome (ARDS)  1  1/69 (1.45%) 
Chronic Obstructive Pulmonary Disease  1  2/69 (2.90%) 
Dyspnea  1  5/69 (7.25%) 
Hemorrhage, pulmonary/upper respiratory  1  1/69 (1.45%) 
Pneumonitis  1  1/69 (1.45%) 
Pneumothorax  1  1/69 (1.45%) 
Pulmonary/Upper Respiratory – Other (Respiratory Arrest)  1  1/69 (1.45%) 
Pulmonary/Upper Respiratory – Other (Hypoxic respiratory failure)  1  1/69 (1.45%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  5/69 (7.25%) 
Vascular - Other (Bilateral carotid occlusion)  1  1/69 (1.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention
Affected / at Risk (%)
Total   69/69 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  46/69 (66.67%) 
Edema  1  26/69 (37.68%) 
Hemorrhage, pulmonary/upper respiratory – Nose  1  5/69 (7.25%) 
Leukocytes  1  6/69 (8.70%) 
Neutrophils  1  30/69 (43.48%) 
Platelets  1  39/69 (56.52%) 
Cardiac disorders   
Cardiac Toxicities (Infarction, Arrythmia)  1  19/69 (27.54%) 
Hypotension  1  4/69 (5.80%) 
Eye disorders   
Watery eye  1  4/69 (5.80%) 
Gastrointestinal disorders   
Anorexia  1  30/69 (43.48%) 
Constipation  1  30/69 (43.48%) 
Dehydration  1  5/69 (7.25%) 
Diarrhea  1  34/69 (49.28%) 
Taste Alteration  1  8/69 (11.59%) 
Mucositis  1  19/69 (27.54%) 
Nausea  1  31/69 (44.93%) 
Vomiting  1  14/69 (20.29%) 
General disorders   
Fatigue  1  56/69 (81.16%) 
Fever (NOS)  1  11/69 (15.94%) 
Pain (NOS)  1  41/69 (59.42%) 
Flu-like syndrome  1  4/69 (5.80%) 
Immune system disorders   
Allergic Reaction  1  8/69 (11.59%) 
Infections and infestations   
Infection (NOS)  1  7/69 (10.14%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  10/69 (14.49%) 
Hypokalemia  1  4/69 (5.80%) 
Hypomagnesemia  1  25/69 (36.23%) 
Hyponatremia  1  4/69 (5.80%) 
Musculoskeletal and connective tissue disorders   
Pain - joints  1  13/69 (18.84%) 
Pain - muscles  1  11/69 (15.94%) 
Nervous system disorders   
Dizziness  1  4/69 (5.80%) 
Neuropathy-sensory  1  9/69 (13.04%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/69 (7.25%) 
Pulmonary Toxicities (dyspnea, pulmonary embolism)  1  43/69 (62.32%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  15/69 (21.74%) 
Pruritus  1  4/69 (5.80%) 
Nail changes  1  8/69 (11.59%) 
Skin toxicities  1  59/69 (85.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193453     History of Changes
Other Study ID Numbers: SCRI LUN 92
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: October 11, 2012
Results First Posted: November 13, 2012
Last Update Posted: November 13, 2012