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Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00871169
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : June 14, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Intervention Drug: Irinotecan, oxaliplatin, and cetuximab
Enrollment 61
Recruitment Details Subjects were recruited at the University of New Mexico Comprehensive Cancer Center between October, 2008, and December, 2014.
Pre-assignment Details  
Arm/Group Title Irinotecan, Oxaliplatin, and Cetuximab
Hide Arm/Group Description

The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)

Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).

The treatment interval (one cycle) is every 14 days.

Period Title: Overall Study
Started 61
Completed 58
Not Completed 3
Reason Not Completed
Protocol Violation             1
Patient did not receive study treatment             2
Arm/Group Title Irinotecan, Oxaliplatin, and Cetuximab
Hide Arm/Group Description

The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)

Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).

The treatment interval (one cycle) is every 14 days.

Overall Number of Baseline Participants 58
Hide Baseline Analysis Population Description
These enrolled patients received study treatment according to the protocol.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 58 participants
62
(39 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
27
  46.6%
Male
31
  53.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Hispanic or Latino
22
  37.9%
Not Hispanic or Latino
35
  60.3%
Unknown or Not Reported
1
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants
58
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. ORR is the percentage of patients who experienced a CR + the percentage of patients who experienced a PR.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Irinotecan, Oxaliplatin, and Cetuximab
Hide Arm/Group Description:

The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)

Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).

The treatment interval (one cycle) is every 14 days.

Overall Number of Participants Analyzed 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.9
(1.91 to 16.7)
2.Secondary Outcome
Title Toxicity
Hide Description Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events, and Serious Adverse Events (SAEs)).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Irinotecan, Oxaliplatin, and Cetuximab
Hide Arm/Group Description:

The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)

Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).

The treatment interval (one cycle) is every 14 days.

Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
Grade 3 Alkaline Phosphatase Increased 4
Grade 3 Allergic Reaction/Hypersensitivity 1
Grade 3 Anorexia 2
Grade 3 Ascites 2
Grade 3 Aspartate Aminotransferase Increased 1
Grade 3 Constipation 3
Grade 3 Creatinine Increased 1
Grade 3 Hemoglobin Decreased 2
Grade 3 Dehydration 1
Grade 3 Diarrhea 1
Grade 3 Limb Edema 1
Grade 3 Fatigue 8
Grade 3 Gamma-glutamyltransferase Increased 2
Grade 3 Hyperbilirubinemia 3
Grade 3 Hyperglycemia 6
Grade 3 Hypoalbuminemia 1
Grade 3 Hypokalemia 11
Grade 3 Hyponatremia 1
Grade 3 Hypophosphatemia 3
Grade 3 Insomnia 1
Grade 3 Leukopenia 1
Grade 3 Nausea 3
Grade 3 Neutropenia 3
Grade 3 Pain - Abdomen 5
Grade 3 Pain - Bone 1
Grade 3 Decreased Respiration 1
Grade 3 Rash 3
Grade 3 Syncope 1
Grade 3 Thrombocytopenia 2
Grade 3 Vomiting 2
Grade 4 Encephalopathy 1
Grade 4 Fatigue 1
Grade 4 Gamma-glutamyltransferase Increased 1
Grade 4 Hyperglycemia 1
Grade 4 Hypokalemia 1
Grade 4 Hypothermia 1
Grade 4 Pleural Effusion 1
SAE: Grade 3 Acidosis 1
SAE: Grade 3 Anorexia 1
SAE: Grade 3 Ascites 1
SAE: Grade 3 Bacteremia 1
SAE: Grade 3 Cholangitis 1
SAE: Grade 3 Dehydration 7
SAE: Grade 3 Diarrhea 1
SAE: Grade 3 Fatigue 1
SAE: Grade 3 Gastrointestinal Hemorrhage 2
SAE: Grade 4 Hyperbilirubinemai 1
SAE: Grade 4 Hyperglycemia 1
SAE: Grade 3 Hypotension 1
SAE: Grade 2 Bowel Obstruction 1
SAE: Grade 3 Bowel Obstruction 2
SAE: Grade 3 Gholangitis 1
SAE: Grade 2 Urinary Tract Infection 1
SAE: Grade 3 Infection of unknown origin 1
SAE: Grade 5 Intracranial Hemorrhage 1
SAE: Grade 2 Mental Status Change 1
SAE: Grade 4 Muscle Weakness 1
SAE: Grade 3 Nausea 1
SAE: Grade 2 Abdominal Pain 1
SAE: Grade 3 Abdominal Pain 4
SAE: Grade 2 Pulmonary embolus 1
SAE: Grade 4 Pulmonary Embolus 2
SAE: Grade 4 Renal Failure 1
SAE: Grade 4 Seizure 1
SAE: Grade 2 Sinus tachycardia 1
SAE: Grade 4 Thrombosis 1
SAE: Grade 3 Vomiting 3
SAE: Grade 3 Weight Loss 1
Time Frame [Not Specified]
Adverse Event Reporting Description Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
 
Arm/Group Title Irinotecan, Oxaliplatin, and Cetuximab
Hide Arm/Group Description

The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)

Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).

The treatment interval (one cycle) is every 14 days.

All-Cause Mortality
Irinotecan, Oxaliplatin, and Cetuximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Irinotecan, Oxaliplatin, and Cetuximab
Affected / at Risk (%) # Events
Total   24/58 (41.38%)    
Cardiac disorders   
Hypotension  1  1/58 (1.72%)  1
Sinus tachycardia  1  1/58 (1.72%)  1
Gastrointestinal disorders   
Anorexia  1  1/58 (1.72%)  1
Ascites  1  1/58 (1.72%)  1
Diarrhea  1  1/58 (1.72%)  1
Ileus (bowel obstruction)  1  3/58 (5.17%)  3
Nausea  1  1/58 (1.72%)  1
Vomiting  1  3/58 (5.17%)  3
General disorders   
Dehydration  1  5/58 (8.62%)  7
Fatigue  1  1/58 (1.72%)  1
Pain - Abdomen  1  5/58 (8.62%)  5
Weight loss  1  1/58 (1.72%)  1
Infections and infestations   
Bacteremia  1  1/58 (1.72%)  1
Cholangitis (Biliary tract infection)  1  1/58 (1.72%)  1
Infection - biliary tract (cholangitis)  1  1/58 (1.72%)  1
Infection - Urinary tract  1  1/58 (1.72%)  1
Infection of unknown origin  1  1/58 (1.72%)  1
Metabolism and nutrition disorders   
Acidosis  1  1/58 (1.72%)  1
Hyperbilirubinemia (Elevated bilirubin)  1  1/58 (1.72%)  1
Hyperglycemia (High blood glucose)  1  1/58 (1.72%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness upper limb  1  1/58 (1.72%)  1
Psychiatric disorders   
Mental status changes  1  1/58 (1.72%)  1
Seizure  1  1/58 (1.72%)  1
Renal and urinary disorders   
Renal failure  1  1/58 (1.72%)  1
Vascular disorders   
Hemorrhage - Gastrointestinal  1  1/58 (1.72%)  2
Intracranial hemorrhage  1  1/58 (1.72%)  1
Pulmonary Emboli  1  3/58 (5.17%)  3
Thrombosis/embolism (vascular access)  1  1/58 (1.72%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Irinotecan, Oxaliplatin, and Cetuximab
Affected / at Risk (%) # Events
Total   56/58 (96.55%)    
Blood and lymphatic system disorders   
Anemia  1  4/58 (6.90%)  5
Decreased hemoglobin  1  11/58 (18.97%)  18
Leukopenia (Decreased leukocytes)  1  6/58 (10.34%)  10
Neutropenia (Decreased neutrophils)  1  16/58 (27.59%)  24
Thrombocytopenia (decreased platelets)  1  8/58 (13.79%)  14
Gastrointestinal disorders   
Abdominal distention  1  5/58 (8.62%)  6
Anorexia  1  22/58 (37.93%)  27
Ascites  1  4/58 (6.90%)  6
Constipation  1  18/58 (31.03%)  23
Diarrhea  1  27/58 (46.55%)  43
Dyspepsia (Heartburn)  1  5/58 (8.62%)  5
Mucositis  1  6/58 (10.34%)  7
Nausea  1  34/58 (58.62%)  56
Taste alteration  1  6/58 (10.34%)  7
Vomiting  1  24/58 (41.38%)  40
General disorders   
Dehydration  1  6/58 (10.34%)  6
Edema - limbs  1  9/58 (15.52%)  10
Fatigue  1  29/58 (50.00%)  53
Fever  1  6/58 (10.34%)  9
Pain - Abdomen  1  19/58 (32.76%)  32
Pain - Back  1  3/58 (5.17%)  3
Rigors/chills  1  4/58 (6.90%)  4
Weight loss  1  20/58 (34.48%)  25
Infections and infestations   
Infection - Urinary tract  1  3/58 (5.17%)  3
Metabolism and nutrition disorders   
Alanine aminotransferase increased  1  4/58 (6.90%)  6
Alkaline phosphatase increased  1  11/58 (18.97%)  14
Aspartate aminotransferase increased  1  5/58 (8.62%)  6
Gamma-glutamyltransferase increased  1  8/58 (13.79%)  11
Hyperbilirubinemia (High bilirubin levels)  1  6/58 (10.34%)  9
Hyperglycemia (High glucose levels)  1  12/58 (20.69%)  25
Hypoalbuminemia (Low blood albumin)  1  12/58 (20.69%)  18
Hypocalcemia (Low calcium levels)  1  10/58 (17.24%)  12
Hypokalemia (Low potassium levels)  1  17/58 (29.31%)  35
Hypomagnesemia (Low magnesium levels)  1  7/58 (12.07%)  11
Hyponatremia (Low sodium levels)  1  6/58 (10.34%)  8
Hypophosphatemia (Low phosphate levels)  1  4/58 (6.90%)  10
Nervous system disorders   
Anxiety  1  4/58 (6.90%)  5
Depression  1  3/58 (5.17%)  3
Dizziness  1  5/58 (8.62%)  5
Insomnia  1  8/58 (13.79%)  10
Peripheral sensory neuropathy  1  16/58 (27.59%)  22
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/58 (5.17%)  4
Dyspnea (Shortness of breath)  1  5/58 (8.62%)  5
Skin and subcutaneous tissue disorders   
Acneiform rash  1  5/58 (8.62%)  5
Alopecia  1  9/58 (15.52%)  11
Dry skin  1  9/58 (15.52%)  9
Pruritis (Itching)  1  4/58 (6.90%)  4
Rash  1  30/58 (51.72%)  44
Vascular disorders   
Hemorrhage - Nasal  1  3/58 (5.17%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 3.0
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: Fa-chyi Lee, MD
Organization: University of New Mexico Comprehensive Cancer Center
Phone: 505-925-0405
EMail: flee@salud.unm.edu
Layout table for additonal information
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00871169     History of Changes
Other Study ID Numbers: INST 0802
NCI-2011-02731 ( Registry Identifier: NCI CTRP )
First Submitted: March 26, 2009
First Posted: March 30, 2009
Results First Submitted: May 6, 2016
Results First Posted: June 14, 2016
Last Update Posted: June 14, 2016