Full Text View
Tabular View
No Study Results Posted
Related Studies
Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
This study has been completed.
Study NCT00053222   Information provided by National Cancer Institute (NCI)
First Received: January 27, 2003   Last Updated: July 23, 2008   History of Changes

January 27, 2003
July 23, 2008
February 2003
 
 
 
Complete list of historical versions of study NCT00053222 on ClinicalTrials.gov Archive Site
 
 
 
Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine

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.

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.

Phase II
Interventional
Treatment, Open Label
Pancreatic Cancer
Drug: arsenic trioxide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053222
 
CDR0000269303, UCCRC-11839A, NCI-5839
University of Chicago
National Cancer Institute (NCI)
Study Chair: Hedy L. Kindler, MD University of Chicago
National Cancer Institute (NCI)
February 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP