Pancreatic CancerPhase 2NCT00064051
3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
A Phase 2 study testing gemcitabine hydrochloride and triapine in people with Pancreatic Cancer, run by Vion Pharmaceuticals at 7 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to… 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?
- gemcitabine hydrochloride and triapine
- How many people
- Not given
- Where
- 7 sitesin 3 countries
- Study dates
- Jan 2003to Aug 2008
- 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 pancreatic cancer
- Unresectable or metastatic disease
- Measurable disease
- Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy
- No CNS metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL (transfusion allowed)
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)
- Chronic viral hepatitis allowed
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No myocardial infarction within the past 3 months
- No uncontrolled congestive heart failure
- No uncontrolled coronary artery disease
- No uncontrolled arrhythmias
Pulmonary
- No dyspnea at rest
- No dependence on supplemental oxygen
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No other malignancy except any of the following:
- Carcinoma in situ of the cervix treated with cone biopsy or resection
- Nonmetastatic basal cell or squamous cell skin cancer
- Any stage I malignancy curatively resected more than 5 years ago
- No active infection
- No known or suspected glucose-6-phosphate dehydrogenase deficiency
- No other concurrent life threatening illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed
Chemotherapy
- No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery
- More than 3 weeks since prior surgery and recovered
Other
- More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease
- No other concurrent investigational drugs
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States4 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, 46202
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, 37203
United Kingdom2 sites
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, SM2 5PT
About this study
Official title: A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES:
- Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine.
- Determine the progression-free interval and survival of patients treated with this regimen.
- Determine the safety and feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 18 months.
PROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24 months.
- Conditions
- Pancreatic Cancer
- Being tested
- gemcitabine hydrochloride, triapine
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, 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.
triapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (partial and complete response) as assessed by RECIST criteria
Secondary outcomes (2)
Progression-free and overall survival
Safety and feasibility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2003 (estimated)
- Study startJan 2003
- Primary completionAug 2006
- Study completionAug 2008
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.
- 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Vion Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mario Sznol, MD, Study chair, Vion Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064051
- Sponsor's protocol ID
- VION-CLI-031
- Other IDs
- CDR0000306461
- Status last verified
- Aug 2008
- First submitted
- 8 Jul 2003
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00064051
- Acronym / sponsor ID
- VION-CLI-031
- Conditions
- Pancreatic Cancer
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Vion PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 Jul 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 such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.
Detailed description
OBJECTIVES:
- Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine.
- Determine the progression-free interval and survival of patients treated with this regimen.
- Determine the safety and feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 18 months.
PROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
| triapine | Drug | – |
Primary outcome
Objective response rate (partial and complete response) as assessed by RECIST criteria
2 secondary outcomes
Progression-free and overall survival
Safety and feasibility
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 2 Aug 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.
Mario Sznol, MD study chair
Vion Pharmaceuticals
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine hydrochloride and triapine in people with Pancreatic Cancer, run by Vion Pharmaceuticals at 7 sites in 3 countries.
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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, United Kingdom, Belgium. 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 rate (partial and complete response) as assessed by RECIST criteria. 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 2 Aug 2013.