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

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