Trial Outcomes & Findings for Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC (NCT NCT00621049)
NCT ID: NCT00621049
Last Updated: 2015-06-08
Results Overview
The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
1 year
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.
|
Docetaxel and Carboplatin
Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.
|
|---|---|---|
|
Adjuvant Treatment
STARTED
|
55
|
57
|
|
Adjuvant Treatment
COMPLETED
|
52
|
47
|
|
Adjuvant Treatment
NOT COMPLETED
|
3
|
10
|
|
Maintenance Treatment
STARTED
|
49
|
0
|
|
Maintenance Treatment
COMPLETED
|
34
|
0
|
|
Maintenance Treatment
NOT COMPLETED
|
15
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC
Baseline characteristics by cohort
| Measure |
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
n=55 Participants
Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.
|
Docetaxel and Carboplatin
n=57 Participants
Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
64 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
57 participants
n=7 Participants
|
112 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.
Outcome measures
| Measure |
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
n=55 Participants
Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.
|
Docetaxel and Carboplatin
n=57 Participants
Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.
|
|---|---|---|
|
Disease-free Survival
|
NA months
Median DFS cannot be calculated for this arm - not enough participants with events required for this calculation
|
55.1 months
Interval 32.9 to
Upper bound of 95% CI cannot be calculated for this arm
|
SECONDARY outcome
Timeframe: 2 yearsAdverse Events occuring in \>15% of patients
Outcome measures
| Measure |
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
n=55 Participants
Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.
|
Docetaxel and Carboplatin
n=57 Participants
Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.
|
|---|---|---|
|
Safety
Dyspnea
|
14 participants
|
17 participants
|
|
Safety
Fatigue
|
37 participants
|
41 participants
|
|
Safety
Nausea
|
32 participants
|
36 participants
|
|
Safety
Diarrhea
|
26 participants
|
24 participants
|
|
Safety
Anemia
|
18 participants
|
28 participants
|
|
Safety
Neutrophil count decreased
|
20 participants
|
26 participants
|
|
Safety
White blood cell decreased
|
18 participants
|
27 participants
|
|
Safety
Alopecia
|
21 participants
|
21 participants
|
|
Safety
Pain
|
23 participants
|
15 participants
|
|
Safety
Platelet count decreased
|
13 participants
|
20 participants
|
|
Safety
Constipation
|
14 participants
|
18 participants
|
|
Safety
Anorexia
|
12 participants
|
18 participants
|
|
Safety
Hyperglycemia
|
18 participants
|
11 participants
|
|
Safety
Dysgeusia
|
12 participants
|
14 participants
|
|
Safety
Mucositis
|
12 participants
|
12 participants
|
|
Safety
Vomiting
|
10 participants
|
13 participants
|
|
Safety
Cough
|
12 participants
|
8 participants
|
|
Safety
Peripheral sensory neuropathy
|
15 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 24 monthsProportion of patients known to still be alive 2 years after coming on study
Outcome measures
| Measure |
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
n=55 Participants
Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.
|
Docetaxel and Carboplatin
n=57 Participants
Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.
|
|---|---|---|
|
2-year Survival
|
78.2 percentage of participants
|
71.9 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsThe Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Outcome measures
| Measure |
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
n=55 Participants
Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.
|
Docetaxel and Carboplatin
n=57 Participants
Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Median OS cannot be calculated for this arm - not enough participants with events required for this calculation
|
NA months
Median OS cannot be calculated for this arm - not enough participants with events required for this calculation
|
Adverse Events
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
Serious events: 14 serious events
Other events: 53 other events
Deaths: 0 deaths
Docetaxel and Carboplatin
Serious events: 14 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
n=55 participants at risk
Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.
|
Docetaxel and Carboplatin
n=57 participants at risk
Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/55
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/55
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/55
|
3.5%
2/57
|
|
Vascular disorders
Thromboembolic event
|
1.8%
1/55
|
1.8%
1/57
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/55
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
1/55
|
0.00%
0/57
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
1/55
|
0.00%
0/57
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/55
|
0.00%
0/57
|
|
Infections and infestations
Bone infection
|
0.00%
0/55
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
1.8%
1/55
|
0.00%
0/57
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/55
|
1.8%
1/57
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, hemorrhage
|
1.8%
1/55
|
0.00%
0/57
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, cholelithiasis
|
1.8%
1/55
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/55
|
0.00%
0/57
|
|
Infections and infestations
Infections and infestations - Other, haemophilus influenza
|
0.00%
0/55
|
1.8%
1/57
|
|
Infections and infestations
Infections and infestations - Other, pneumonia
|
1.8%
1/55
|
0.00%
0/57
|
|
Infections and infestations
Infections and infestations - Other, pseudomona bacteremia
|
1.8%
1/55
|
0.00%
0/57
|
|
Infections and infestations
Infections and infestations - Other, unspecified
|
0.00%
0/55
|
1.8%
1/57
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/55
|
1.8%
1/57
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/55
|
1.8%
1/57
|
|
Gastrointestinal disorders
Pancreatitis
|
1.8%
1/55
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/55
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.8%
1/55
|
0.00%
0/57
|
|
Infections and infestations
Sepsis
|
0.00%
0/55
|
1.8%
1/57
|
Other adverse events
| Measure |
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
n=55 participants at risk
Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1
Docetaxel should be administered before carboplatin.
After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:
Maintenance Treatment for patients in Cohort A:
Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily
Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.
|
Docetaxel and Carboplatin
n=57 participants at risk
Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1
Docetaxel should be administered before carboplatin.
Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.
|
|---|---|---|
|
General disorders
Fatigue
|
67.3%
37/55
|
71.9%
41/57
|
|
Gastrointestinal disorders
Nausea
|
58.2%
32/55
|
63.2%
36/57
|
|
Gastrointestinal disorders
Diarrhea
|
47.3%
26/55
|
42.1%
24/57
|
|
Blood and lymphatic system disorders
Anemia
|
32.7%
18/55
|
49.1%
28/57
|
|
Investigations
Neutrophil count decreased
|
36.4%
20/55
|
45.6%
26/57
|
|
Investigations
White blood cell decreased
|
32.7%
18/55
|
47.4%
27/57
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.2%
21/55
|
36.8%
21/57
|
|
General disorders
Pain
|
41.8%
23/55
|
26.3%
15/57
|
|
Investigations
Platelet count decreased
|
23.6%
13/55
|
35.1%
20/57
|
|
Gastrointestinal disorders
Constipation
|
25.5%
14/55
|
31.6%
18/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.5%
14/55
|
29.8%
17/57
|
|
Metabolism and nutrition disorders
Anorexia
|
21.8%
12/55
|
31.6%
18/57
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
32.7%
18/55
|
19.3%
11/57
|
|
Nervous system disorders
Dysgeusia
|
21.8%
12/55
|
24.6%
14/57
|
|
Gastrointestinal disorders
Mucositis
|
21.8%
12/55
|
21.1%
12/57
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
10/55
|
22.8%
13/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.8%
12/55
|
14.0%
8/57
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
27.3%
15/55
|
3.5%
2/57
|
|
Renal and urinary disorders
Proteinuria
|
23.6%
13/55
|
5.3%
3/57
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.7%
7/55
|
12.3%
7/57
|
|
General disorders
Fever
|
12.7%
7/55
|
10.5%
6/57
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.5%
8/55
|
7.0%
4/57
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.7%
7/55
|
8.8%
5/57
|
|
Metabolism and nutrition disorders
Dehydration
|
10.9%
6/55
|
8.8%
5/57
|
|
Psychiatric disorders
Insomnia
|
10.9%
6/55
|
8.8%
5/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
6/55
|
7.0%
4/57
|
|
Nervous system disorders
Dizziness
|
9.1%
5/55
|
8.8%
5/57
|
|
General disorders
General disorders and administration site conditions - Other, hemorrhage
|
12.7%
7/55
|
5.3%
3/57
|
|
Vascular disorders
Hypertension
|
10.9%
6/55
|
5.3%
3/57
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
5/55
|
7.0%
4/57
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
10.9%
6/55
|
5.3%
3/57
|
|
Nervous system disorders
Headache
|
7.3%
4/55
|
7.0%
4/57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other, body ache
|
3.6%
2/55
|
10.5%
6/57
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
4/55
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.3%
4/55
|
5.3%
3/57
|
|
Infections and infestations
Infections and infestations - Other, unknown
|
1.8%
1/55
|
10.5%
6/57
|
|
Investigations
Weight loss
|
7.3%
4/55
|
5.3%
3/57
|
|
Immune system disorders
Allergic reaction
|
7.3%
4/55
|
3.5%
2/57
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
2/55
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, unknown
|
7.3%
4/55
|
3.5%
2/57
|
Additional Information
John D Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
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 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