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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00053222
Enrollment
13
Registered
2003-01-28
Start date
2003-02-28
Completion date
2007-07-31
Last updated
2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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

DRUGarsenic trioxide

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Objective response3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026