Trial Outcomes & Findings for Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer (NCT NCT00193453)
NCT ID: NCT00193453
Last Updated: 2012-11-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
18 months
Results posted on
2012-11-13
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
69
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Intervention
n=69 Participants
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).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=5 Participants
|
|
Age Continuous
|
68 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=65 Participants
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 Clinical Response Rate
|
17 Percentage of participants
Interval 9.0 to 29.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for progression-free survival.
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.
Outcome measures
| Measure |
Intervention
n=69 Participants
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).
|
|---|---|
|
Progression Free Survival (PFS)
|
4.0 Months
Interval 2.7 to 5.9
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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.
The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Outcome measures
| Measure |
Intervention
n=65 Participants
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).
|
|---|---|
|
Response Duration
|
7.0 Months
Interval 2.5 to 8.9
|
Adverse Events
Intervention
Serious events: 43 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=69 participants at risk
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).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome (ARDS)
|
1.4%
1/69
|
|
Immune system disorders
Allergic reaction
|
4.3%
3/69
|
|
Cardiac disorders
Atrial fibrillation
|
5.8%
4/69
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Abnormal EKG)
|
1.4%
1/69
|
|
Cardiac disorders
Cardiac Arrythmia (NOS)
|
1.4%
1/69
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
5.8%
4/69
|
|
Cardiac disorders
Cardiopulmonary arrest
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
2.9%
2/69
|
|
General disorders
Death not associated with CTCAE term - Disease Progression NOS
|
8.7%
6/69
|
|
Gastrointestinal disorders
Dehydration
|
4.3%
3/69
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
2/69
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.2%
5/69
|
|
Blood and lymphatic system disorders
Edema
|
1.4%
1/69
|
|
General disorders
Fatigue
|
2.9%
2/69
|
|
General disorders
Fever
|
1.4%
1/69
|
|
Blood and lymphatic system disorders
Hemorrhage, GI - Peritoneal cavity
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
1.4%
1/69
|
|
Infections and infestations
Infection - Other (Cellulitis)
|
1.4%
1/69
|
|
Infections and infestations
Infection - Other (Pneumonia)
|
7.2%
5/69
|
|
Blood and lymphatic system disorders
Neutrophils
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Respiratory Arrest)
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Hypoxic respiratory failure)
|
1.4%
1/69
|
|
Renal and urinary disorders
Renal failure
|
2.9%
2/69
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
1.4%
1/69
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
7.2%
5/69
|
|
Vascular disorders
Vascular - Other (Bilateral carotid occlusion)
|
1.4%
1/69
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/69
|
Other adverse events
| Measure |
Intervention
n=69 participants at risk
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).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.7%
15/69
|
|
Blood and lymphatic system disorders
Hemoglobin
|
66.7%
46/69
|
|
Gastrointestinal disorders
Anorexia
|
43.5%
30/69
|
|
Musculoskeletal and connective tissue disorders
Pain - joints
|
18.8%
13/69
|
|
Cardiac disorders
Cardiac Toxicities (Infarction, Arrythmia)
|
27.5%
19/69
|
|
Gastrointestinal disorders
Constipation
|
43.5%
30/69
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
5/69
|
|
Gastrointestinal disorders
Dehydration
|
7.2%
5/69
|
|
Gastrointestinal disorders
Diarrhea
|
49.3%
34/69
|
|
Nervous system disorders
Dizziness
|
5.8%
4/69
|
|
Gastrointestinal disorders
Taste Alteration
|
11.6%
8/69
|
|
Blood and lymphatic system disorders
Edema
|
37.7%
26/69
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
7.2%
5/69
|
|
General disorders
Fatigue
|
81.2%
56/69
|
|
General disorders
Fever (NOS)
|
15.9%
11/69
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.5%
10/69
|
|
Eye disorders
Watery eye
|
5.8%
4/69
|
|
Immune system disorders
Allergic Reaction
|
11.6%
8/69
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.8%
4/69
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
36.2%
25/69
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.8%
4/69
|
|
Cardiac disorders
Hypotension
|
5.8%
4/69
|
|
Infections and infestations
Infection (NOS)
|
10.1%
7/69
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.8%
4/69
|
|
Blood and lymphatic system disorders
Leukocytes
|
8.7%
6/69
|
|
Gastrointestinal disorders
Mucositis
|
27.5%
19/69
|
|
Musculoskeletal and connective tissue disorders
Pain - muscles
|
15.9%
11/69
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
11.6%
8/69
|
|
Gastrointestinal disorders
Nausea
|
44.9%
31/69
|
|
Blood and lymphatic system disorders
Neutrophils
|
43.5%
30/69
|
|
General disorders
Pain (NOS)
|
59.4%
41/69
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Toxicities (dyspnea, pulmonary embolism)
|
62.3%
43/69
|
|
Nervous system disorders
Neuropathy-sensory
|
13.0%
9/69
|
|
Skin and subcutaneous tissue disorders
Skin toxicities
|
85.5%
59/69
|
|
Blood and lymphatic system disorders
Platelets
|
56.5%
39/69
|
|
Gastrointestinal disorders
Vomiting
|
20.3%
14/69
|
|
General disorders
Flu-like syndrome
|
5.8%
4/69
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER