Phase II Trial of Irinotecan/Docetaxel for Advanced Pancreatic Cancer, With Randomization Between Irinotecan/Docetaxel and Irinotecan/Docetaxel Plus C225 a Monoclonal Antibody to the Epidermal Growth Factor Receptor (EGF-r)
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase II Trial of Irinotecan/Docetaxel for Advanced Pancreatic Cancer, With Randomization Between Irinotecan/Docetaxel and Irinotecan/Docetaxel Plus C225 a Monoclonal Antibody to the Epidermal Growth Factor Receptor (EGF-r)
OBJECTIVES:
- Determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms
of objective response rate, in patients with metastatic adenocarcinoma of the pancreas.
- Determine the time to progression and overall survival of patients treated with these
regimens.
- Determine the proportion of patients with tumors that overexpress epidermal growth
factor receptor.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm A: Patients receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes
weekly on days 1, 8, 15, and 22.
- Arm B: Patients receive docetaxel and irinotecan as in arm A. Patients also receive
cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36.
Courses repeat in both arms every 6 weeks in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 1 year, and then
periodically thereafter.
PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm)
Inclusion Criteria:
- Histologically confirmed metastatic adenocarcinoma of the pancreas
- Sufficient tumor tissue from fine needle aspiration, core biopsy, or open biopsy
available for epidermal growth factor receptor testing
- At least 1 unidimensionally measurable primary or metastatic lesionge
- Age of 18 and over
- ECOG performance status 0-1
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine clearance > 60 mL/min
- LVEF normal
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Bilirubin ≤ upper limit of normal (ULN)*
- SGOT or SGPT and alkaline phosphatase must meet the criteria for 1 of the following*:
- SGOT or SGPT ≤ 2.5 times ULN AND alkaline phosphatase ≤ ULN
- SGOT or SGPT ≤ 1.5 times ULN AND alkaline phosphatase > ULN but ≤ 2.5 times ULN
- SGOT or SGPT ≤ ULN AND alkaline phosphatase > 2.5 but ≤ 4 times ULN
NOTE: *Percutaneous stenting or endoscopic retrograde cholangiopancreatography may be used
to normalize liver function tests
Exclusion Criteria:
- History of uncontrolled arrhythmias
- History of congestive heart failure
- History of uncontrolled angina pectoris
- Prior chemotherapy
- Pre-existing neuropathy ≥ grade 2
- Prior hypersensitivity to polysorbate 80
- Pregnant or nursing
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria)
Outcome Description:
Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR
Outcome Time Frame:
Assessed every 12 weeks until progression
Safety Issue:
No
Principal Investigator
Barbara A. Burtness, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000069486
NCT ID:
NCT00042939
Start Date:
July 2003
Completion Date:
August 2009
Related Keywords:
- Pancreatic Cancer
- pancreatic cancer
- metastatic pancreatic cancer
- EGF-r
- irinotecan
- docetaxel
- cetuximab
- Pancreatic Neoplasms
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