Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Gemcitabine

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