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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Irinotecan, oxaliplatin, and cetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||INST 0802: Phase II Trial of Combination Irinotecan, Oxaliplatin and Cetuximab for Patients With Locally Advanced or Metastatic Pancreatic Cancer|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: Irinotecan, oxaliplatin, and cetuximab
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)
Drug: 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 Response Rate (ORR) [ Time Frame: 2 years ]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.
- Toxicity [ Time Frame: 2 years ]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)).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871169
|United States, New Mexico|
|University of New Mexico Cancer Center @ Lovelace Medical Center|
|Albuquerque, New Mexico, United States, 87102|
|Hematology Oncology Associates|
|Albuquerque, New Mexico, United States, 87106|
|Cancer Center at Presbyterian Hospital|
|Albuquerque, New Mexico, United States, 87110|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87131-0001|
|Memorial Medical Center- Cancer Center|
|Las Cruces, New Mexico, United States, 88011|
|Principal Investigator:||Fa-Chyi Lee, M.D.||University of New Mexico Cancer Center|