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

The University of Chicago

Status and phase

Completed

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: arsenic trioxide

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00053222

11839A

NCI-5839

UCCRC-11839A

Details and patient eligibility

About

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.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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