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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00053222 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have locally advanced or metastatic pancreatic cancer that has not responded to gemcitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: arsenic trioxide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine |
| Study Start Date: | February 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 9-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Unidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| LaGrange Memorial Hospital | |
| LaGrange, Illinois, United States, 60525 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Michigan | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| Study Chair: | Hedy L. Kindler, MD | University of Chicago |
More Information
| ClinicalTrials.gov Identifier: | NCT00053222 History of Changes |
| Other Study ID Numbers: | CDR0000269303, UCCRC-11839A, NCI-5839 |
| Study First Received: | January 27, 2003 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
recurrent pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Arsenic trioxide |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |