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

Information source: Eastern Cooperative Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer

Intervention: cetuximab (Biological); docetaxel (Drug); irinotecan hydrochloride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Barbara A. Burtness, MD, Study Chair, Affiliation: Fox Chase Cancer Center

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 .

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria)

Secondary outcome:

Progression-free Survival

Overall Survival

Epidermal Growth Factor Receptor (EGFR) Status

Proportion of Patients With Thromboembolic Events

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2003
Last updated: April 2, 2013

Page last updated: August 23, 2015

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