Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .

Further Study Information

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)

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Barbara A. Burtness

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00042939
Information obtained from ClinicalTrials.gov on December 15, 2011

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