Status:
COMPLETED
Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hy...
Detailed Description
The investigators will evaluate the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinoteca...
Eligibility Criteria
Inclusion
- All patients, 18 years of age or older, with histology proven pancreatic cancer are eligible.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \>= 1,500 or cells/mm3 and platelet count \>= 60,000/mm3 and absence of a regular red blood cell transfusion requirement.
- Patients should have adequate hepatic function with a total bilirubin \<= 4.0 mg/dl, could be \<= 10 mg/ml if biliary drainage tube is placed and functional in a newly diagnosed patient, and SGOT or SGPT \<= four times the upper limit of normal, and adequate renal function as defined by a serum creatinine \<= 1.5 x upper limit of normal.
- For patients that had been treated with one of the study medications will be allowed as long as the treatment did not contain more than 2 study medications at the same time. For example, irinotecan and capecitabine combination will be allowed but not irinotecan and cetuximab. Similarly, gemcitabine with cetuximab will be allowed but not gemcitabine, oxaliplatin and cetuximab. Treated with irinotecan alone followed by oxaliplatin will be allowed but not when irinotecan was in combination with oxaliplatin.
- Patients are allowed to have up to 2 prior treatments. The protocol will also include chemotherapy naïve patients.
Exclusion
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
- Known hypersensitivity reaction to any of the study medications.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00871169
Start Date
October 1 2008
End Date
April 1 2015
Last Update
June 14 2016
Active Locations (5)
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1
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
2
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
3
Cancer Center at Presbyterian Hospital
Albuquerque, New Mexico, United States, 87110
4
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-0001