Trial Outcomes & Findings for Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery (NCT NCT00408564)
NCT ID: NCT00408564
Last Updated: 2018-07-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
up to 46 weeks after the start of study treatment
Results posted on
2018-07-23
Participant Flow
Participant milestones
| Measure |
Gemcitabine,Oxaliplatin and Cetuximab
Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.
After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.
cetuximab
capecitabine
oxaliplatin
conventional surgery
neoadjuvant therapy
radiation therapy
Gemcitabine
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Gemcitabine,Oxaliplatin and Cetuximab
n=39 Participants
Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.
After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 46 weeks after the start of study treatmentPopulation: only includes patients who completed at least 2 cycles of induction chemotherapy.
Outcome measures
| Measure |
Gemcitabine,Oxaliplatin and Cetuximab
n=38 Participants
Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.
After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.
|
|---|---|
|
Progression-free Survival at 6 Months
|
82 percentage of participants
Interval 70.0 to 95.0
|
SECONDARY outcome
Timeframe: from start of study treatment until end of study visit, about 30 weeksOutcome measures
| Measure |
Gemcitabine,Oxaliplatin and Cetuximab
n=39 Participants
Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.
After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.
|
|---|---|
|
Number of Participants With Grade 3-4 Adverse Events Reported
|
9 participants
|
SECONDARY outcome
Timeframe: up to 46 weeks after the start of study treatmentOutcome measures
| Measure |
Gemcitabine,Oxaliplatin and Cetuximab
n=38 Participants
Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.
After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.
|
|---|---|
|
Overall Survival
|
49 percentage of participants
Interval 36.0 to 68.0
|
SECONDARY outcome
Timeframe: up to 46 weeks after the start of study treatmentPopulation: only includes patients who completed at least 2 cycles of induction chemotherapy.
defined as the total number of subjects whose best response is PR or CR.
Outcome measures
| Measure |
Gemcitabine,Oxaliplatin and Cetuximab
n=38 Participants
Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.
After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.
|
|---|---|
|
Response Rate
|
5 Participants
|
SECONDARY outcome
Timeframe: up to 46 weeks after the start of study treatmentPopulation: data for this endpoint was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from start up treatment to one year after end of treatment, up to 81 weeksPopulation: data for this endpoint was not collected.
Outcome measures
Outcome data not reported
Adverse Events
Gemcitabine,Oxaliplatin and Cetuximab
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine,Oxaliplatin and Cetuximab
n=39 participants at risk
Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.
After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.
|
|---|---|
|
Gastrointestinal disorders
vomiting
|
15.4%
6/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Investigations
metabolic acidosis
|
5.1%
2/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory insufficiency
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Musculoskeletal and connective tissue disorders
fractured right arm
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Gastrointestinal disorders
abdominal pain
|
5.1%
2/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Renal and urinary disorders
urinary tract infection
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Musculoskeletal and connective tissue disorders
weakness
|
5.1%
2/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Cardiac disorders
bradycardia
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Gastrointestinal disorders
dehydration
|
5.1%
2/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Renal and urinary disorders
billiary obstruction
|
5.1%
2/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
General disorders
fever
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
General disorders
fall
|
5.1%
2/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Gastrointestinal disorders
anorexia
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
General disorders
edema
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Hepatobiliary disorders
jaundice
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Psychiatric disorders
altered mental status
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Musculoskeletal and connective tissue disorders
pain
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Gastrointestinal disorders
nausea
|
15.4%
6/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
General disorders
weight loss
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Gastrointestinal disorders
diarrhea
|
5.1%
2/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.1%
2/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
Gastrointestinal disorders
fecal impaction
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
|
General disorders
allergic reaction
|
2.6%
1/39 • Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
"Other adverse event" information is not available for reporting.
|
Other adverse events
Adverse event data not reported
Additional Information
Kate Anderton, MPH, CCRP
Medical University of South Carolina
Phone: 843-792-2708
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place