NCT00053222
Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
PHASE2
COMPLETED
NCT00053222
INTERVENTIONAL
A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine
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.
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
Pancreatic Cancer
- TREATMENT
-
- Type: DRUG
- Name: arsenic trioxide
- Description:
- Arm Group Labels: Arm A
- University of Chicago