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INST 0802: Phase II Trial of Combination Irinotecan, Oxaliplatin and Cetuximab for Patients With Locally Advanced or Metastatic Pancreatic Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

INST 0802: Phase II Trial of Combination Irinotecan, Oxaliplatin and Cetuximab for Patients With Locally Advanced or Metastatic Pancreatic Cancer


Inclusion Criteria:



1. All patients, 18 years of age or older, with histology proven pancreatic cancer are
eligible.

2. Patients must have a life expectancy of at least 12 weeks.

3. Patients must have a Zubrod performance status of 0-2.

4. Patients must sign an informed consent.

5. 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.

6. 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.

7. 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.

8. Patients are allowed to have up to 2 prior treatments. The protocol will also include
chemotherapy naïve patients.

Exclusion Criteria:

1. Patients with symptomatic brain metastases are excluded from this study.

2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

3. Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

4. Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.

5. Known hypersensitivity reaction to any of the study medications.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the efficacy of combination irinotecan, oxaliplatin and cetuximab for patients with diagnosis of pancreatic cancers.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Fa-Chyi Lee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

INST 0802

NCT ID:

NCT00871169

Start Date:

October 2008

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Cancer
  • Irinotecan
  • Oxaliplatin
  • Cetuximab
  • Advanced or metastatic pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Hematology Oncology AssociatesAlbuquerque, New Mexico  87106
University of New Mexico Cancer Center @ Lovelace Medical CenterAlbuquerque, New Mexico  87102
Cancer Center at Presbyterian HospitalAlbuquerque, New Mexico  87110
Memorial Medical Center- Cancer CenterLas Cruces, New Mexico  88011