Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Cetuximab; Docetaxel; Irinotecan

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