Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00042939

Purpose

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 .

Condition	Intervention	Phase
Pancreatic Cancer	Biological: cetuximab Drug: docetaxel Drug: irinotecan hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Irinotecan U 101440E Docetaxel Irinotecan hydrochloride Cetuximab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate by RECIST every 12 weeks [ Designated as safety issue: No ]
Objective partial or complete response as measured by scan at 6 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression by RECIST criteria [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Proportion of epidermal growth factor receptor-positive tumors [ Designated as safety issue: No ]
Rate of thromboembolic events [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	July 2003

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 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.

PROJECTED ACCRUAL: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042939

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Barbara A. Burtness, MD

Fox Chase Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000069486, ECOG-E8200
Study First Received:	August 5, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00042939 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Irinotecan
Cetuximab
Endocrine System Diseases
Enzyme Inhibitors
Pharmacologic Actions

Camptothecin
Docetaxel
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Pancreatic Diseases
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009