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

NCT00053222 | Completed Phase 2

• 3 other identifiers: 11839AUCCRC-11839ANCI-5839
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 11

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.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Objective response

  3 years

Study Arms (1)

Arm A

EXPERIMENTAL

Arsenic trioxide (0.3 mg/kg/day iv for 5 days every 28 days)

Drug: arsenic trioxide

Interventions

arsenic trioxide DRUG

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care - Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

LaGrange Memorial Hospital

LaGrange, Illinois, 60525, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Incorporated

Fort Wayne, Indiana, 46885-5099, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Hedy L. Kindler, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2003
• First Posted: January 28, 2003
• Study Start: February 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: July 1, 2007
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (11)