Pancreatic CancerPhase 2NCT00053222
Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
A Phase 2 study testing arsenic trioxide in people with Pancreatic Cancer, run by University of Chicago at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- arsenic trioxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2003to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201-1781
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, 46885-5099
Ingalls Memorial Hospital
Harvey, Illinois, 60426
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
Loyola University Medical Center
Maywood, Illinois, 60153
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, 49085
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- arsenic trioxide
- Keywords
- recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arsenic trioxideDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arsenic trioxide (0.3 mg/kg/day iv for 5 days every 28 days) Receives: Drug: arsenic trioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startFeb 2003
- Primary completionJan 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hedy L. Kindler, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053222
- Sponsor's protocol ID
- 11839A
- Other IDs
- UCCRC-11839A, NCI-5839
- Status last verified
- Sep 2013
- First submitted
- 27 Jan 2003
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine
- ClinicalTrials.gov ID
- NCT00053222
- Acronym / sponsor ID
- 11839A
- Conditions
- Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 28 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: arsenic trioxideArsenic trioxide (0.3 mg/kg/day iv for 5 days every 28 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arsenic trioxide | Drug | Arm A |
Primary outcome
Objective response
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hedy L. Kindler, MD study chair
University of Chicago
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing arsenic trioxide in people with Pancreatic Cancer, run by University of Chicago at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.