Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-E8200 E8200, NCT00042939

Objectives

1. 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.
2. Determine the time to progression and overall survival of patients treated with these regimens.
3. Determine the proportion of patients with tumors that overexpress epidermal growth factor receptor.

Entry Criteria

Disease Characteristics:

• 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 lesion

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³

Hepatic

• 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]

Renal

• Creatinine clearance > 60 mL/min

Cardiovascular

• No history of uncontrolled arrhythmias
• No history of congestive heart failure
• No history of uncontrolled angina pectoris
• LVEF normal

Other

• No pre-existing neuropathy ≥ grade 2
• No prior hypersensitivity to polysorbate 80
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 92 patients (46 per treatment arm) (arm II closed to accrual as of 4/13/06) will be accrued for this study.

Outcomes

Response rate by RECIST every 12 weeks
Objective partial or complete response as measured by scan at 6 weeks

Time to progression by RECIST criteria
Overall survival
Proportion of epidermal growth factor receptor-positive tumors
Rate of thromboembolic events

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Patients also receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes weekly on days 1, 8, 15, and 22.



• Arm II (closed to accrual as of 4/13/06): Patients receive docetaxel and irinotecan as in arm I.

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.

Burtness BA, Powell ME, Berlin JD, et al.: Phase II ECOG trial of irinotecan/docetaxel with or without cetuximab in metastatic pancreatic cancer: updated survival and CA19-9 results. [Abstract] J Clin Oncol 26 (Suppl 15): A-4642, 2008.

Burtness BA, Powell M, Berlin J, et al.: 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) : Eastern Cooperative Oncology. [Abstract] J Clin Oncol 25 (Suppl 18): A-4519, 2007.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Barbara Burtness, MD, Protocol chair		Ph: 215-728-3023; 888-369-2427

Registry Information
Official Title		A Phase II Trial Of Irinotecan/Docetaxel For Advanced Cancer, With Randomization Between Irinotecan/Docetaxel Plus C225, A Monoclonal Antibody To The Epidermal Growth Factor Receptor (EGF-R)
Trial Start Date		2003-07-29
Registered in ClinicalTrials.gov		NCT00042939
Date Submitted to PDQ		2002-06-10
Information Last Verified		2006-09-01
NCI Grant/Contract Number		CA21115

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