Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic 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:

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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