Trial Outcomes & Findings for Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy (NCT NCT00766636)
NCT ID: NCT00766636
Last Updated: 2016-05-19
Results Overview
Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report
TERMINATED
PHASE2
5 participants
Following resection performed at time of surgery, day 36 of treatment +/- 5 days
2016-05-19
Participant Flow
Recruitment Period: September 4, 2008 to December 7, 2009. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.
Of the 5 participants enrolled, one withdrew consent and the others did not complete treatment.
Participant milestones
| Measure |
Gemcitabine + Erlotinib Without Radiation
Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M\^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum.
|
Gemcitabine + Erlotinib With Radiation
Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M\^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Gemcitabine + Erlotinib Without Radiation
Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M\^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum.
|
Gemcitabine + Erlotinib With Radiation
Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M\^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Incomplete Treatment
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Disease Progression
|
1
|
0
|
Baseline Characteristics
Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy
Baseline characteristics by cohort
| Measure |
Gemcitabine + Erlotinib Without Radiation
n=3 Participants
Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M\^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum.
|
Gemcitabine + Erlotinib With Radiation
n=2 Participants
Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M\^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
67.5 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following resection performed at time of surgery, day 36 of treatment +/- 5 daysPopulation: The study was terminated early without enough patients to perform any analysis between the groups. Of the five registered, one withdrew prior to any treatment and the others either had disease progression or left prior to surgery with incomplete preoperative regimen.
Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report
Outcome measures
Outcome data not reported
Adverse Events
Gemcitabine + Erlotinib Without Radiation
Gemcitabine + Erlotinib With Radiation
Serious adverse events
| Measure |
Gemcitabine + Erlotinib Without Radiation
n=3 participants at risk
Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M\^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum.
|
Gemcitabine + Erlotinib With Radiation
n=2 participants at risk
Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M\^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/3 • Adverse events (AEs) were assessed from the time of consent until two years following surgery. Collection Period: September 2008 to April 2011.
|
50.0%
1/2 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until two years following surgery. Collection Period: September 2008 to April 2011.
|
|
General disorders
Chest Pain
|
0.00%
0/3 • Adverse events (AEs) were assessed from the time of consent until two years following surgery. Collection Period: September 2008 to April 2011.
|
50.0%
1/2 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until two years following surgery. Collection Period: September 2008 to April 2011.
|
Other adverse events
Adverse event data not reported
Additional Information
Jason B. Fleming, MD / Surgical Oncology
University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place