Trial Outcomes & Findings for Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer (NCT NCT00366457)
NCT ID: NCT00366457
Last Updated: 2017-05-15
Results Overview
Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
all patients will be followed for a minimum of 4 months
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
|
|---|---|
|
Overall Study
never began study therapy
|
2
|
Baseline Characteristics
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine, Bevacizumab and Erlotinib
n=30 Participants
single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: all patients will be followed for a minimum of 4 monthsPopulation: participants who started treatment
Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Gemcitabine, Bevacizumab and Erlotinib
n=30 Participants
single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
|
|---|---|
|
Time to Tumor Progression
|
3.5 months
Interval 2.6 to 5.6
|
SECONDARY outcome
Timeframe: after at least one 28-day cycle of treatmentPopulation: participants with response data available
Response rate using RECIST criteria and latest time point available. 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.
Outcome measures
| Measure |
Gemcitabine, Bevacizumab and Erlotinib
n=28 Participants
single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
|
|---|---|
|
Response Rate
Partial Response
|
1 Participants
|
|
Response Rate
Progressive Disease
|
8 Participants
|
|
Response Rate
Stable Disease
|
19 Participants
|
SECONDARY outcome
Timeframe: during and after first 28-day cycle of treatmentPopulation: participants who started treatment
Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening
Outcome measures
| Measure |
Gemcitabine, Bevacizumab and Erlotinib
n=30 Participants
single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
|
|---|---|
|
Toxicity Profile
Anorexia
|
1 Participants
|
|
Toxicity Profile
Neutrophils
|
4 Participants
|
|
Toxicity Profile
ALT-SGPT
|
3 Participants
|
|
Toxicity Profile
Fatigue
|
2 Participants
|
|
Toxicity Profile
Leukocytes
|
2 Participants
|
|
Toxicity Profile
Rash: acne/acneiform
|
2 Participants
|
|
Toxicity Profile
Thrombosis/thrombus/embolism
|
2 Participants
|
|
Toxicity Profile
AST - SGOT
|
1 Participants
|
|
Toxicity Profile
Hemoglobin
|
1 Participants
|
|
Toxicity Profile
Lymphopenia
|
1 Participants
|
|
Toxicity Profile
Nonneuropathic generalized weakness
|
1 Participants
|
|
Toxicity Profile
Upper GI-hemorrhage NOS
|
1 Participants
|
|
Toxicity Profile
Vascular access-Thrombosis/embolism
|
1 Participants
|
|
Toxicity Profile
Vessel injury - artery - Other NOS
|
1 Participants
|
|
Toxicity Profile
Weight loss
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: participants who started treatment
overall survival (OS) = time from study entry until death from any cause
Outcome measures
| Measure |
Gemcitabine, Bevacizumab and Erlotinib
n=30 Participants
single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
|
|---|---|
|
Overall Survival
|
6.7 months
Interval 4.9 to 11.7
|
Adverse Events
Gemcitabine, Bevacizumab and Erlotinib
Serious events: 11 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Bevacizumab and Erlotinib
n=30 participants at risk
single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pumonary embolism
|
13.3%
4/30 • Number of events 4
|
|
Endocrine disorders
Death from disease progression
|
10.0%
3/30 • Number of events 3
|
|
Infections and infestations
Death from infection or sepsis
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Brain Infarct
|
3.3%
1/30 • Number of events 1
|
|
Immune system disorders
Neutropenia
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine, Bevacizumab and Erlotinib
n=30 participants at risk
single-arm, no masking
Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
|
|---|---|
|
General disorders
Fatigue
|
83.3%
25/30 • Number of events 102
|
|
Blood and lymphatic system disorders
Leukocytes
|
83.3%
25/30 • Number of events 84
|
|
Gastrointestinal disorders
Nausea
|
80.0%
24/30 • Number of events 73
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
76.7%
23/30 • Number of events 91
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
76.7%
23/30 • Number of events 71
|
|
Blood and lymphatic system disorders
Platelets
|
73.3%
22/30 • Number of events 80
|
|
Metabolism and nutrition disorders
ALT- SGPT
|
73.3%
22/30 • Number of events 76
|
|
Blood and lymphatic system disorders
Hemoglobin
|
70.0%
21/30 • Number of events 78
|
|
Blood and lymphatic system disorders
Neutrophils
|
70.0%
21/30 • Number of events 67
|
|
Metabolism and nutrition disorders
AST- SGOT
|
66.7%
20/30 • Number of events 77
|
|
General disorders
Abdomen - pain
|
66.7%
20/30 • Number of events 47
|
|
Gastrointestinal disorders
Anorexia
|
63.3%
19/30 • Number of events 48
|
|
Gastrointestinal disorders
Constipation
|
56.7%
17/30 • Number of events 34
|
|
Metabolism and nutrition disorders
Hyponatremia
|
56.7%
17/30 • Number of events 27
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
53.3%
16/30 • Number of events 61
|
|
General disorders
Weight loss
|
50.0%
15/30 • Number of events 35
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
15/30 • Number of events 25
|
|
General disorders
Rigors/chills
|
50.0%
15/30 • Number of events 20
|
|
Blood and lymphatic system disorders
Lymphopenia
|
46.7%
14/30 • Number of events 30
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
43.3%
13/30 • Number of events 25
|
|
General disorders
Nose- hemorrhage
|
36.7%
11/30 • Number of events 19
|
|
General disorders
Fever w/o neutropenia
|
36.7%
11/30 • Number of events 12
|
|
Metabolism and nutrition disorders
Bilirubin
|
33.3%
10/30 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
30.0%
9/30 • Number of events 24
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.0%
9/30 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
9/30 • Number of events 15
|
|
General disorders
Insomnia
|
30.0%
9/30 • Number of events 14
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
26.7%
8/30 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
23.3%
7/30 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
23.3%
7/30 • Number of events 12
|
|
Gastrointestinal disorders
Dehydration
|
23.3%
7/30 • Number of events 9
|
|
General disorders
Head/headache
|
20.0%
6/30 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
6/30 • Number of events 12
|
|
Gastrointestinal disorders
Muco/stomatitis by exam- oral cavity
|
20.0%
6/30 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
6/30 • Number of events 8
|
|
General disorders
Extremity-limb- pain
|
20.0%
6/30 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
6/30 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
5/30 • Number of events 23
|
|
Cardiac disorders
Hypertension
|
16.7%
5/30 • Number of events 22
|
|
Metabolism and nutrition disorders
Proteinuria
|
16.7%
5/30 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
5/30 • Number of events 13
|
|
Nervous system disorders
Depression
|
16.7%
5/30 • Number of events 11
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
5/30 • Number of events 10
|
|
Blood and lymphatic system disorders
Edema limb
|
16.7%
5/30 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
16.7%
5/30 • Number of events 8
|
|
Metabolism and nutrition disorders
Bicarbonate
|
16.7%
5/30 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
5/30 • Number of events 5
|
|
General disorders
Muscle- pain
|
16.7%
5/30 • Number of events 5
|
|
Gastrointestinal disorders
GI-other
|
13.3%
4/30 • Number of events 7
|
|
General disorders
Back- pain
|
13.3%
4/30 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
13.3%
4/30 • Number of events 6
|
|
Infections and infestations
Infection Gr0-2 neut- upper airway
|
13.3%
4/30 • Number of events 5
|
|
General disorders
Chest/thoracic pain NOS
|
13.3%
4/30 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • Number of events 10
|
|
Nervous system disorders
Neurologic-other
|
10.0%
3/30 • Number of events 6
|
|
Immune system disorders
Allergic reaction
|
10.0%
3/30 • Number of events 4
|
|
Nervous system disorders
Anxiety
|
10.0%
3/30 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
3/30 • Number of events 4
|
|
General disorders
Pain-other
|
10.0%
3/30 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
10.0%
3/30 • Number of events 4
|
|
General disorders
Throat/pharynx/larynx- pain
|
10.0%
3/30 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
10.0%
3/30 • Number of events 3
|
|
Eye disorders
Ocular-other
|
10.0%
3/30 • Number of events 3
|
|
General disorders
Pain NOS
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Taste disturbance
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Distention/bloating- abdominal
|
6.7%
2/30 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.7%
2/30 • Number of events 4
|
|
Nervous system disorders
Neuropathy-sensory
|
6.7%
2/30 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.7%
2/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Burn
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Flu-like syndrome
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Joint- pain
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Rectum- hemorrhage
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Rectum- pain
|
6.7%
2/30 • Number of events 2
|
|
Renal and urinary disorders
Renal/GU-other
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Sweating
|
6.7%
2/30 • Number of events 2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.7%
2/30 • Number of events 2
|
Additional Information
Lawrence S. Blaszkowsky, MD
Massachusetts General Hospital
Phone: 6172191230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place