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A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine


- 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

Inclusion Criteria


- 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



- Over 18

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- AST/ALT no greater than 5 times upper limit of normal


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min


- 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


- 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


Biologic therapy

- No concurrent immunotherapy

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


- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and

- No prior arsenic trioxide

- No other concurrent chemotherapy

- No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy

- No concurrent hormonal therapy


- At least 4 weeks since prior radiotherapy and recovered

- No concurrent therapeutic radiotherapy


- At least 4 weeks since major surgery


- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

February 2003

Completion Date:

July 2007

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
Loyola University Medical Center Maywood, Illinois  60153
Ingalls Memorial Hospital Harvey, Illinois  60426
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Evanston Northwestern Health Care - Evanston Hospital Evanston, Illinois  60201
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
LaGrange Memorial Hospital LaGrange, Illinois  60525