Trial Outcomes & Findings for 7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients (NCT NCT00841035)

Results Overview

It was our belief that we would need a comprehensive analysis of a dynamic panel of biomarkers relevant to EGFR signaling as well as the erlotinib mechanism of action it seems more useful in that sense. Furthermore,the ability limited of pancreatic cancer tissue sampling precluded biomarker correlation assays.These could not be worked out in either a xenograft model or in in-vitro conditions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

During the trial only

Results posted on

2017-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Eroltinib Added to Standard of Care 150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles.
Phase 1 Overall Study STARTED	19
Phase 1 Overall Study COMPLETED	6
Phase 1 Overall Study NOT COMPLETED	13
Phase 2 of Overall Study STARTED	6
Phase 2 of Overall Study COMPLETED	6
Phase 2 of Overall Study NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Eroltinib Added to Standard of Care 150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles.
Phase 1 Overall Study Physician Decision	13

Baseline Characteristics

7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eroltinib Added to Standard of Care n=19 Participants 150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: During the trial only

It was our belief that we would need a comprehensive analysis of a dynamic panel of biomarkers relevant to EGFR signaling as well as the erlotinib mechanism of action it seems more useful in that sense. Furthermore,the ability limited of pancreatic cancer tissue sampling precluded biomarker correlation assays.These could not be worked out in either a xenograft model or in in-vitro conditions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of the study

Population: Due to the closure of the study before this endpoint could be met, there are no subjects analyzed.

The measurement was to be the average length of time before recurrence of disease and the overall survival time. As well as time from recurrence to death in subjects.This time will be measure in months till recurrence and them months to death.

Outcome measures

Outcome data not reported

Adverse Events

Eroltinib Added to Standard of Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Eroltinib Added to Standard of Care n=19 participants at risk 150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles.
Cardiac disorders Chest Pain	5.3% 1/19 • Number of events 1 • Baseline to 36 month or subject death.

Additional Information

Research Nurse Supervisor of Clinical trials

University of Alabama at Birmingham

Phone: (205)975-0450

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place