Trial Outcomes & Findings for Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery (NCT NCT00482625)

NCT ID: NCT00482625

Last Updated: 2014-10-16

Results Overview

Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Pre-treatment and post-treatment

Results posted on

2014-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Enzyme Inhibitor Therapy) Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Enzyme Inhibitor Therapy) n=6 Participants Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Age, Continuous	61.17 years STANDARD_DEVIATION 14.48 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-treatment and post-treatment

Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=3 Participants Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment	2 participants

SECONDARY outcome

Timeframe: 20 weeks

Plasma concentration levels of Erlotinib (OSI-774)

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=4 Participants Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Plasma Calculated Concentration - OSI-774 (ng/mL)	428.5 ng/mL Standard Deviation 290.4

SECONDARY outcome

Timeframe: 20 weeks

Pancreatic tissue concentration levels of Erlotinib (OSI-774)

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=4 Participants Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Pancreas Calculated Concentration - OSI-774 (ng/g)	188.7 ng/g Standard Deviation 121.7

SECONDARY outcome

Timeframe: 20 weeks

Plasma concentration levels of Erlotinib (OSI-420)

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=4 Participants Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Plasma Calculated Concentration - OSI-420 (ng/mL)	27.6 ng/mL Standard Deviation 21.3

SECONDARY outcome

Timeframe: 20 weeks

Pancreatic tissue concentration levels of Erlotinib (OSI-420)

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=4 Participants Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Pancreas Calculated Concentration - OSI-420 (ng/g)	17.3 ng/g Standard Deviation 7.2

SECONDARY outcome

Timeframe: Up to 20 weeks

The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=6 Participants Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above	0 participants

Adverse Events

Treatment (Enzyme Inhibitor Therapy)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Enzyme Inhibitor Therapy) n=6 participants at risk Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery. erlotinib hydrochloride: Given PO conventional surgery: Undergo pancreatectomy immunohistochemistry staining method: Correlative studies protein expression analysis: Correlative studies biopsy: Correlative studies pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders DIARRHEA	50.0% 3/6 • Number of events 3 • All adverse events are reported and docuemted during the study
Gastrointestinal disorders DIFFICULTY DIGESTING FOOD-UPPER GI	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Eye disorders DRY EYES	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Skin and subcutaneous tissue disorders DRY SKIN	33.3% 2/6 • Number of events 2 • All adverse events are reported and docuemted during the study
Skin and subcutaneous tissue disorders DRY SKIN ON BODY	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Skin and subcutaneous tissue disorders DRY SKIN ON CHEEK AND CORNERS OF MOUTH	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
General disorders FATIGUE	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Nervous system disorders HEADACHE	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Psychiatric disorders INSOMNIA	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Musculoskeletal and connective tissue disorders LEG, FOOT, ANKLE CRAMPS	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Gastrointestinal disorders LOSS OF APPETITE	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Investigations OUT OF RANGE LYMPHOCYTE VALUE-CLINICALLY SIGNIFICANT	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Investigations OUT OF RANGE NEUTROPHIL VALUE-CLINICALLY SIGNIFICANT	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Investigations OUT OF RANGE WBC VALUE-CLINICALLY SIGNIFICANT	16.7% 1/6 • Number of events 1 • All adverse events are reported and docuemted during the study
Skin and subcutaneous tissue disorders RASH	33.3% 2/6 • Number of events 3 • All adverse events are reported and docuemted during the study

Additional Information

Dr. Steven Lipkin

Weill Cornell College of Medicine

Phone: 212-774-7160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60