Clinical trial · Interventional
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
NCT00053222CI-TRIAL-00012012completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Arsenic trioxide (0.3 mg/kg/day iv for 5 days every 28 days)
- interventionNames
- Drug: arsenic trioxide
Primary outcomes (1)
- measure
- Objective response
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.