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Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
This study has been completed.
First Received: January 27, 2003   Last Updated: July 23, 2008   History of Changes
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: Treatment, Open Label
Official Title: A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine

Resource links provided by NLM:


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

Study Start Date: February 2003
Detailed Description:

OBJECTIVES:

  • Determine the objective response rate to arsenic trioxide in patients with pancreatic cancer who have progressed after first-line treatment with a gemcitabine-containing regimen when treated with arsenic trioxide.
  • Determine the toxicity of this drug in these patients.
  • Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Locally advanced or metastatic disease
  • Unidimensionally measurable disease

    • At least 1 lesion that is at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
  • Must have progressed after chemotherapy with a gemcitabine-containing regimen
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • AST/ALT no greater than 5 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • QTc less than 500 msec at baseline by EKG
  • No New York Heart Association class III or IV heart failure
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to arsenic trioxide
  • No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy
  • No concurrent colony-stimulating factors during the first course of the study

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior arsenic trioxide
  • No other concurrent chemotherapy
  • No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy

  • No concurrent hormonal therapy

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent therapeutic radiotherapy

Surgery

  • At least 4 weeks since major surgery

Other

  • No other concurrent investigational or commercial anticancer agents or therapies
  • No other concurrent investigational agents
  • No concurrent antiretroviral therapy in HIV-positive patients
  • No concurrent medications for other comorbid conditions that are known to prolong the QT interval
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053222

Locations
United States, Illinois
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
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
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Michigan
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States, 49085
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Hedy L. Kindler, MD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000269303, UCCRC-11839A, NCI-5839
Study First Received: January 27, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00053222     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Arsenic trioxide
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009