Trial Outcomes & Findings for Paclitaxel, Bevacizumab and Pemetrexed in Patients With Untreated, Advanced Non-Small Cell Lung Cancer Using Web-Based Data Collection, Patient Self-Reporting of Adverse Effects and Automated Response Assessment (NCT NCT00807573)
NCT ID: NCT00807573
Last Updated: 2015-12-30
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
2 years
Results posted on
2015-12-30
Participant Flow
Participant milestones
| Measure |
Paclitaxel, Bevacizumab & Pemetrexed
Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m\^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m\^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
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|---|---|
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Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Paclitaxel, Bevacizumab & Pemetrexed
Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m\^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m\^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Paclitaxel, Bevacizumab and Pemetrexed in Patients With Untreated, Advanced Non-Small Cell Lung Cancer Using Web-Based Data Collection, Patient Self-Reporting of Adverse Effects and Automated Response Assessment
Baseline characteristics by cohort
| Measure |
Paclitaxel, Bevacizumab & Pemetrexed
n=44 Participants
Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced NSCLC. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1, 15 and 19.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Paclitaxel, Bevacizumab & Pemetrexed
n=42 Participants
Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m\^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m\^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
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|---|---|
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Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease.
Partial Response
|
27 participants
|
|
Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease.
Stable Disease
|
15 participants
|
Adverse Events
Paclitaxel, Bevacizumab & Pemetrexed
Serious events: 20 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel, Bevacizumab & Pemetrexed
n=44 participants at risk
Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m\^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m\^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
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|---|---|
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General disorders
Death not assoc w CTCAE term- Death NOS
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.8%
3/44 • Number of events 3
|
|
General disorders
Edema: limb
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
4.5%
2/44 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/44 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
1/44 • Number of events 2
|
|
Investigations
Hemoglobin
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
2/44 • Number of events 2
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Pneumonia(lung)
|
4.5%
2/44 • Number of events 3
|
|
Infections and infestations
Infection, other
|
6.8%
3/44 • Number of events 3
|
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Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Neuropathy: cranial - CN II Vision
|
2.3%
1/44 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
4.5%
2/44 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
4.5%
2/44 • Number of events 3
|
|
Gastrointestinal disorders
Perforation, GI- Small Bowel NOS
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulm infiltrates
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulm/upp respiratory - Other (spec)
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Vessel injury-artery- Other NOS
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
2.3%
1/44 • Number of events 1
|
Other adverse events
| Measure |
Paclitaxel, Bevacizumab & Pemetrexed
n=44 participants at risk
Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m\^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m\^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
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|---|---|
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Investigations
ALT, SGPT
|
47.7%
21/44 • Number of events 116
|
|
Investigations
AST, SGOT
|
25.0%
11/44 • Number of events 32
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
29.5%
13/44 • Number of events 37
|
|
Metabolism and nutrition disorders
Anorexia
|
47.7%
21/44 • Number of events 70
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.8%
14/44 • Number of events 35
|
|
Investigations
Creatinine
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
50.0%
22/44 • Number of events 84
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
68.2%
30/44 • Number of events 213
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
79.5%
35/44 • Number of events 176
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
22.7%
10/44 • Number of events 49
|
|
Investigations
Hemoglobin
|
40.9%
18/44 • Number of events 123
|
|
Investigations
INR
|
4.5%
2/44 • Number of events 8
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
47.7%
21/44 • Number of events 87
|
|
Blood and lymphatic system disorders
Lymphopenia
|
43.2%
19/44 • Number of events 162
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
22.7%
10/44 • Number of events 26
|
|
Gastrointestinal disorders
Nausea
|
25.0%
11/44 • Number of events 35
|
|
Nervous system disorders
Neuropathy: sensory
|
20.5%
9/44 • Number of events 21
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
40.9%
18/44 • Number of events 45
|
|
Investigations
PTT
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
47.7%
21/44 • Number of events 66
|
|
General disorders
Pain - Pain NOS
|
63.6%
28/44 • Number of events 143
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
18.2%
8/44 • Number of events 13
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
13.6%
6/44 • Number of events 9
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
9.1%
4/44 • Number of events 5
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
4.5%
2/44 • Number of events 7
|
|
Nervous system disorders
Voice changes/dysarthria
|
18.2%
8/44 • Number of events 33
|
Additional Information
Dr. Maria Pietanza, Assistant Attending
Memorial Sloan Kettering Cancer Center
Phone: +1646-888-4203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place