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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
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

11839A

NCT ID:

NCT00053222

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Loyola University Medical CenterMaywood, Illinois  60153
Ingalls Memorial HospitalHarvey, Illinois  60426
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Evanston Northwestern Health Care - Evanston HospitalEvanston, Illinois  60201
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
LaGrange Memorial HospitalLaGrange, Illinois  60525