Trial Outcomes & Findings for A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer (NCT NCT00336700)
NCT ID: NCT00336700
Last Updated: 2016-09-19
Results Overview
The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 60 months
Results posted on
2016-09-19
Participant Flow
Participant milestones
| Measure |
Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)
Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)
n=25 Participants
Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsThe time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.
Outcome measures
| Measure |
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)
n=25 Participants
Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
|
|---|---|
|
Recurrence Free Survival (RFS)
|
14 months
Interval 8.2 to 24.5
|
PRIMARY outcome
Timeframe: Up to 60 monthsOutcome measures
| Measure |
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)
n=25 Participants
Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
|
|---|---|
|
1-year Recurrence Free Survival (RFS)
|
56 percentage of participants
Interval 35.0 to 73.0
|
PRIMARY outcome
Timeframe: Up to 60 monthsOutcome measures
| Measure |
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)
n=25 Participants
Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
|
|---|---|
|
2-year Recurrence Free Survival (RFS)
|
26 percentage of participants
Interval 6.0 to 52.0
|
SECONDARY outcome
Timeframe: Up to 60 monthsTime from from date of first study therapy to to death from any cause.
Outcome measures
| Measure |
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)
n=25 Participants
Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
|
|---|---|
|
Estimated 1&2 Year Overall Survival (OS)
Estimated 1-year OS
|
84 percentage of participants
Interval 63.0 to 94.0
|
|
Estimated 1&2 Year Overall Survival (OS)
Estimated 2-year OS
|
53 percentage of participants
Interval 22.0 to 76.0
|
SECONDARY outcome
Timeframe: Up to 60 monthsPercentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).
Outcome measures
| Measure |
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)
n=25 Participants
Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
|
|---|---|
|
Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
EGFR FISH - Negative
|
80 percentage of participants
|
|
Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
EGFR FISH - Positive
|
20 percentage of participants
|
|
Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
EGFR IHC - 1+ (incomplete circumferential)
|
22 percentage of participants
|
|
Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
2+ (complete circumferential)
|
35 percentage of participants
|
|
Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
3+ (complete strong circumferential)
|
43 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 60 monthsKRAS mutation status in resected tumor specimens.
Outcome measures
| Measure |
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)
n=25 Participants
Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
|
|---|---|
|
KRAS Mutational Status
|
92 percentage of participants
|
Adverse Events
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)
n=25 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Blood/bone marrow
|
12.0%
3/25
|
|
Gastrointestinal disorders
Gastrointestinal
|
8.0%
2/25
|
|
General disorders
Constitutional symptoms
|
4.0%
1/25
|
|
Immune system disorders
Allergy/immunology
|
4.0%
1/25
|
|
Infections and infestations
Infection
|
16.0%
4/25
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Pain
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin
|
12.0%
3/25
|
Other adverse events
| Measure |
Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)
n=25 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
40.0%
10/25
|
|
Eye disorders
Dry eye syndrome
|
8.0%
2/25
|
|
Eye disorders
Ocular/Visual - Other
|
12.0%
3/25
|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic), Oral cavity
|
8.0%
2/25
|
|
Gastrointestinal disorders
Pain, Abdomen NOS
|
12.0%
3/25
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
16.0%
4/25
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
16.0%
4/25
|
|
Gastrointestinal disorders
Vomiting
|
32.0%
8/25
|
|
Gastrointestinal disorders
Nausea
|
36.0%
9/25
|
|
Gastrointestinal disorders
Diarrhea
|
72.0%
18/25
|
|
General disorders
Constitutional Symptoms - Other
|
8.0%
2/25
|
|
General disorders
Rigors/chills
|
8.0%
2/25
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)
|
28.0%
7/25
|
|
General disorders
Weight loss
|
36.0%
9/25
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
68.0%
17/25
|
|
Infections and infestations
Infection - Other
|
8.0%
2/25
|
|
Infections and infestations
Infection with unknown ANC, Urinary tract NOS
|
8.0%
2/25
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
12.0%
3/25
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
16.0%
4/25
|
|
Investigations
Alkaline phosphatase
|
20.0%
5/25
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
24.0%
6/25
|
|
Investigations
Leukocytes (total WBC)
|
24.0%
6/25
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
28.0%
7/25
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
24.0%
6/25
|
|
Metabolism and nutrition disorders
Anorexia
|
28.0%
7/25
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
44.0%
11/25
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Extraocular
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
12.0%
3/25
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
12.0%
3/25
|
|
Nervous system disorders
Dizziness
|
12.0%
3/25
|
|
Nervous system disorders
Pain, Head/headache
|
16.0%
4/25
|
|
Psychiatric disorders
Mood alteration, Anxiety
|
8.0%
2/25
|
|
Psychiatric disorders
Mood alteration, Depression
|
8.0%
2/25
|
|
Psychiatric disorders
Insomnia
|
12.0%
3/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation, Chemoradiation
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
16.0%
4/25
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
24.0%
6/25
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
36.0%
9/25
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
48.0%
12/25
|
|
Vascular disorders
Hypotension
|
12.0%
3/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place