Pancreatic Cancer
Conditions
Keywords
recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Brief 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.
Detailed 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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response | 3 years |
Countries
United States