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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075686 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in 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. It is not yet known whether gemcitabine is more effective with or without cetuximab in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: cetuximab Drug: gemcitabine hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine As First-Line Therapy Of Patients With Advanced Pancreas Cancer |
Study Start Date: | January 2004 |
OBJECTIVES:
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to disease status (locally advanced unresectable vs metastatic), Zubrod performance status (0 or 1 vs 2), and prior pancreatectomy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, before each course, and at the end of study therapy.
Patients are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 704 patients (352 per treatment arm) will be accrued for this study within 5 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically* or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria:
None of the following tumor types are allowed:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Philip A. Philip, MD, PhD, FRCP | Barbara Ann Karmanos Cancer Institute |
Study Chair: | Eileen O'Reilly, MD | Memorial Sloan-Kettering Cancer Center |
Study Chair: | Ralph P. W. Wong, MD, FRCPC | CancerCare Manitoba |
Study ID Numbers: | CDR0000347414, SWOG-S0205, CALGB-S0205, CAN-NCIC-PAC1 |
Study First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075686 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the pancreas stage III pancreatic cancer stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Cetuximab Endocrine System Diseases Pancrelipase Carcinoma Digestive System Diseases |
Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents |
Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |