Trial Outcomes & Findings for Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC) (NCT NCT00673738)
NCT ID: NCT00673738
Last Updated: 2015-10-08
Results Overview
Progression Free Survival is defined as the interval between the date of the first cetuximab administration and the date of objective progression of disease. Progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2015-10-08
Participant Flow
Participants were recruited at Moffitt Cancer Center from May, 2008 to November, 2010.
Participant milestones
| Measure |
Cetuximab Plus Radiotherapy
Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)
Baseline characteristics by cohort
| Measure |
Cetuximab Plus Radiotherapy
n=27 Participants
Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: All participants
Progression Free Survival is defined as the interval between the date of the first cetuximab administration and the date of objective progression of disease. Progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Cetuximab Plus Radiotherapy
n=27 Participants
Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
7.5 months
Interval 4.0 to 10.7
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All participants
Overall survival is defined as the time from randomization until death from any cause.
Outcome measures
| Measure |
Cetuximab Plus Radiotherapy
n=27 Participants
Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
|
|---|---|
|
Median Overall Survival (OS)
|
10.5 months
Interval 4.3 to 20.5
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All participants
ORR = Complete Response (CR) + Partial Response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response: Disappearance of all target lesions; Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Cetuximab Plus Radiotherapy
n=27 Participants
Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
|
|---|---|
|
Overall Response Rate (ORR)
Partial Response
|
59.3 percentage of participants
Interval 38.8 to 77.6
|
|
Overall Response Rate (ORR)
Complete Response
|
0 percentage of participants
There was no occurrence of Complete Response.
|
Adverse Events
Cetuximab Plus Radiotherapy
Serious events: 20 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab Plus Radiotherapy
n=27 participants at risk
Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
3.7%
1/27 • 3 years
|
|
Blood and lymphatic system disorders
Low Neutrophils/granulocytes (ANC/AGC)
|
7.4%
2/27 • 3 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
3.7%
1/27 • 3 years
|
|
Cardiac disorders
Hypotension
|
7.4%
2/27 • 3 years
|
|
General disorders
Sweating (diaphoresis)
|
3.7%
1/27 • 3 years
|
|
General disorders
Death not associated with CTCAE term - Death
|
7.4%
2/27 • 3 years
|
|
General disorders
Death not associated with CTCAE term - Sudden death
|
7.4%
2/27 • 3 years
|
|
Gastrointestinal disorders
Anorexia
|
3.7%
1/27 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • 3 years
|
|
Gastrointestinal disorders
Dehydration
|
11.1%
3/27 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • 3 years
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
11.1%
3/27 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
7.4%
2/27 • 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
3.7%
1/27 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
7.4%
2/27 • 3 years
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic), GI - Esophagus
|
7.4%
2/27 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS
|
3.7%
1/27 • 3 years
|
|
Infections and infestations
Febrile neutropenia
|
14.8%
4/27 • 3 years
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung
|
3.7%
1/27 • 3 years
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urinary Tract
|
3.7%
1/27 • 3 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Esophagus
|
3.7%
1/27 • 3 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
14.8%
4/27 • 3 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
|
3.7%
1/27 • 3 years
|
|
Blood and lymphatic system disorders
Edema: limb
|
3.7%
1/27 • 3 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
3.7%
1/27 • 3 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
3.7%
1/27 • 3 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
7.4%
2/27 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
3.7%
1/27 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
3.7%
1/27 • 3 years
|
|
General disorders
Mood alteration - Agitation
|
3.7%
1/27 • 3 years
|
|
General disorders
Pain - Abdomen NOS
|
3.7%
1/27 • 3 years
|
|
General disorders
Pain - Throat/pharynx/larynx
|
3.7%
1/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
18.5%
5/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
3.7%
1/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
3/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
14.8%
4/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.7%
1/27 • 3 years
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
3.7%
1/27 • 3 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
11.1%
3/27 • 3 years
|
Other adverse events
| Measure |
Cetuximab Plus Radiotherapy
n=27 participants at risk
Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
|
|---|---|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
70.4%
19/27 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
70.4%
19/27 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
55.6%
15/27 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
51.9%
14/27 • 3 years
|
|
Gastrointestinal disorders
Anorexia
|
40.7%
11/27 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
9/27 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
6/27 • 3 years
|
|
Gastrointestinal disorders
Dehydration
|
18.5%
5/27 • 3 years
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic), GI - Esophagus
|
14.8%
4/27 • 3 years
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
14.8%
4/27 • 3 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.4%
2/27 • 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis clinical exam) - Oral cavity
|
7.4%
2/27 • 3 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
81.5%
22/27 • 3 years
|
|
General disorders
Weight loss
|
18.5%
5/27 • 3 years
|
|
General disorders
Constitutional Symptoms - Other
|
14.8%
4/27 • 3 years
|
|
General disorders
Insomnia
|
14.8%
4/27 • 3 years
|
|
Infections and infestations
Fever (in the absence of neutropenia)
|
7.4%
2/27 • 3 years
|
|
General disorders
Sweating (diaphoresis)
|
7.4%
2/27 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Radiation
|
74.1%
20/27 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
70.4%
19/27 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
66.7%
18/27 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
9/27 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
18.5%
5/27 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
7.4%
2/27 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.4%
2/27 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.4%
2/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
63.0%
17/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
51.9%
14/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
14.8%
4/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
3/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
7.4%
2/27 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
7.4%
2/27 • 3 years
|
|
General disorders
Pain - Head/headache
|
22.2%
6/27 • 3 years
|
|
General disorders
Pain - Back
|
14.8%
4/27 • 3 years
|
|
General disorders
Pain - Chest/thorax NOS
|
14.8%
4/27 • 3 years
|
|
General disorders
Pain - Throat/pharynx/larynx
|
14.8%
4/27 • 3 years
|
|
General disorders
Pain - Abdomen NOS
|
11.1%
3/27 • 3 years
|
|
General disorders
Pain - Esophagus
|
7.4%
2/27 • 3 years
|
|
General disorders
Pain - Other
|
7.4%
2/27 • 3 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
14.8%
4/27 • 3 years
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin)
|
11.1%
3/27 • 3 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus
|
7.4%
2/27 • 3 years
|
|
Infections and infestations
Infection with unknown ANC - Oral cavity-gums (gingivitis)
|
7.4%
2/27 • 3 years
|
|
General disorders
Dizziness
|
22.2%
6/27 • 3 years
|
|
General disorders
Confusion
|
7.4%
2/27 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
18.5%
5/27 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness generalized or specific area (not due to neuropathy) whole body/generalized
|
14.8%
4/27 • 3 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
14.8%
4/27 • 3 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
7.4%
2/27 • 3 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
7.4%
2/27 • 3 years
|
|
Blood and lymphatic system disorders
Edema: limb
|
14.8%
4/27 • 3 years
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
7.4%
2/27 • 3 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
14.8%
4/27 • 3 years
|
|
Cardiac disorders
Hypotension
|
14.8%
4/27 • 3 years
|
|
Eye disorders
Ocular/Visual - Other
|
7.4%
2/27 • 3 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
7.4%
2/27 • 3 years
|
|
Blood and lymphatic system disorders
Low Neutrophils/granulocytes (ANC/AGC)
|
7.4%
2/27 • 3 years
|
Additional Information
Alberto Chiappori, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place