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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

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ClinicalTrials.gov Identifier: NCT00408564
Recruitment Status : Completed
First Posted : December 7, 2006
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin
Procedure: conventional surgery
Radiation: radiation therapy
Drug: Gemcitabine
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemcitabine,Oxaliplatin and Cetuximab
Hide Arm/Group Description

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

Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Gemcitabine,Oxaliplatin and Cetuximab
Hide Arm/Group Description

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 Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
  76.9%
>=65 years
9
  23.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
17
  43.6%
Male
22
  56.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  20.5%
White
30
  76.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.6%
1.Primary Outcome
Title Progression-free Survival at 6 Months
Hide Description [Not Specified]
Time Frame up to 46 weeks after the start of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
only includes patients who completed at least 2 cycles of induction chemotherapy.
Arm/Group Title Gemcitabine,Oxaliplatin and Cetuximab
Hide Arm/Group Description:

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 Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82
(70 to 95)
2.Secondary Outcome
Title Number of Participants With Grade 3-4 Adverse Events Reported
Hide Description [Not Specified]
Time Frame from start of study treatment until end of study visit, about 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine,Oxaliplatin and Cetuximab
Hide Arm/Group Description:

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 Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
9
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame up to 46 weeks after the start of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine,Oxaliplatin and Cetuximab
Hide Arm/Group Description:

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 Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49
(36 to 68)
4.Secondary Outcome
Title Response Rate
Hide Description defined as the total number of subjects whose best response is PR or CR.
Time Frame up to 46 weeks after the start of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
only includes patients who completed at least 2 cycles of induction chemotherapy.
Arm/Group Title Gemcitabine,Oxaliplatin and Cetuximab
Hide Arm/Group Description:

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 Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
5
  13.2%
5.Secondary Outcome
Title Response Duration in Patients With at Least Partial Response to Treatment
Hide Description [Not Specified]
Time Frame up to 46 weeks after the start of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
data for this endpoint was not collected.
Arm/Group Title Gemcitabine,Oxaliplatin and Cetuximab
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Determine the Biomarker Response of CA 19-9 to Therapy
Hide Description [Not Specified]
Time Frame from start up treatment to one year after end of treatment, up to 81 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
data for this endpoint was not collected.
Arm/Group Title Gemcitabine,Oxaliplatin and Cetuximab
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events will be assessed from the start of study therapy until the end of therapy visit (up to 13 weeks).
Adverse Event Reporting Description "Other adverse event" information is not available for reporting.
 
Arm/Group Title Gemcitabine,Oxaliplatin and Cetuximab
Hide Arm/Group Description

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.

All-Cause Mortality
Gemcitabine,Oxaliplatin and Cetuximab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine,Oxaliplatin and Cetuximab
Affected / at Risk (%)
Total   13/39 (33.33%) 
Cardiac disorders   
bradycardia   1/39 (2.56%) 
Gastrointestinal disorders   
vomiting   6/39 (15.38%) 
abdominal pain   2/39 (5.13%) 
dehydration   2/39 (5.13%) 
anorexia   1/39 (2.56%) 
nausea   6/39 (15.38%) 
diarrhea   2/39 (5.13%) 
fecal impaction   1/39 (2.56%) 
General disorders   
fever   1/39 (2.56%) 
fall   2/39 (5.13%) 
edema   1/39 (2.56%) 
weight loss   1/39 (2.56%) 
allergic reaction   1/39 (2.56%) 
Hepatobiliary disorders   
jaundice   1/39 (2.56%) 
Investigations   
metabolic acidosis   2/39 (5.13%) 
Metabolism and nutrition disorders   
hypokalemia   2/39 (5.13%) 
Musculoskeletal and connective tissue disorders   
fractured right arm   1/39 (2.56%) 
weakness   2/39 (5.13%) 
pain   1/39 (2.56%) 
Psychiatric disorders   
altered mental status   1/39 (2.56%) 
Renal and urinary disorders   
urinary tract infection   1/39 (2.56%) 
billiary obstruction   2/39 (5.13%) 
Respiratory, thoracic and mediastinal disorders   
respiratory insufficiency   1/39 (2.56%) 
pulmonary edema   1/39 (2.56%) 
pleural effusion   1/39 (2.56%) 
acute respiratory distress   1/39 (2.56%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gemcitabine,Oxaliplatin and Cetuximab
Affected / at Risk (%)
Total   0/39 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kate Anderton, MPH, CCRP
Organization: Medical University of South Carolina
Phone: 843-792-2708
EMail: anderton@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00408564     History of Changes
Other Study ID Numbers: CDR0000518313
MUSC-100918
BMS-MUSC-100918
SANOFI-MUSC-100918
First Submitted: December 6, 2006
First Posted: December 7, 2006
Results First Submitted: May 23, 2018
Results First Posted: July 23, 2018
Last Update Posted: July 23, 2018