Pancreatic CancerPhase 2NCT00544908
Dasatinib in Treating Patients With Stage IV Pancreatic Cancer
A Phase 2 study testing dasatinib, immunoenzyme technique and immunohistochemistry staining method in people with Pancreatic Cancer, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with stage IV pancreatic cancer. 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?
- dasatinib, immunoenzyme technique and immunohistochemistry staining method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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* confirmed pancreatic cancer
- Stage IV disease NOTE: *If biopsy was performed at an outside facility, the histology must be reviewed and confirmed by the Division of Pathology at the City of Hope
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 3 months
- Platelet count ≥ 100,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Bilirubin ≤ 1.5 mg/dL
- ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 mg/dL and/or creatinine clearance > 60 mL/min
- PT and PTT ≤ 1.5 times ULN
- Able to swallow dasatinib whole
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
- No concurrent medical condition which may increase the risk of toxicity, including any of the following:
- Pleural or pericardial effusion of any grade
- Clinically significant coagulation or platelet function disorder (e.g., known von Willebrand's disease)
- None of the following cardiac conditions:
- Uncontrolled angina, congestive heart failure, or myocardial infarction within the past 6 months
- Prolonged QTc interval (i.e., QTc > 450 msec) on electrocardiogram
- History of clinically significant ventricular arrhythmias (i.e., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- No hypokalemia or hypomagnesemia that cannot be corrected
- No severe infection requiring treatment
- Completely recovered from other concurrent illnesses, as deemed by the investigator
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Recovered from prior major surgery
- No prior irradiation to the planned field
- No prior chemotherapy for pancreatic cancer
- At least 7 days since prior and no concurrent medications that may prolong the QT interval, including any of the following:
- Quinidine
- Procainamide
- Disopyramide
- Amiodarone
- Sotalol
- Ibutilide
- Dofetilide
- Erythromycin
- Clarithromycin
- Chlorpromazine
- Haloperidol
- Mesoridazine
- Thioridazine
- Pimozide
- Cisapride
- Bepridil
- Droperidol
- Methadone
- Arsenic
- Chloroquine
- Domperidone
- Halofantrine
- Levomethadyl
- Pentamidine
- Sparfloxacin
- Lidoflazine
- At least 7 days since prior and no concurrent potent CYP3A4 inhibitors
- At least 7 days since prior and no concurrent medications that directly and durably inhibit platelet function, including any of the following:
- Aspirin or aspirin-containing combinations
- Clopidogrel
- Dipyridamole
- Tirofiban
- Dipyridamole
- Epoprostenol
- Eptifibatide
- Cilostazol
- Abciximab
- Ticlopidine
- Cilostazol
- No concurrent anticoagulants, including warfarin or heparin/low molecular weight heparin (e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin)
- Low-dose warfarin for prophylaxis to prevent catheter thrombosis or heparin for flushes of IV lines allowed
- No concurrent IV bisphosphonates during the first 8 weeks of dasatinib therapy
- No concurrent Hypericum perforatum (St. Johns wort)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
City of Hope Medical Group
Pasadena, California, 91105
About this study
Official title: A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with stage IV pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the 4-month progression-free survival (PFS) rate in patients with stage IV pancreatic cancer treated with dasatinib.
Secondary
- To evaluate the response rate (complete and partial response) in patients treated with this drug.
- To evaluate the median PFS and overall survival of patients treated with this drug.
- To study the toxicities and tolerability of this drug in these patients.
- To evaluate the impact of this drug on quality of life measures.
- To evaluate the impact of this drug on Src and FAK in peripheral blood mononuclear cells prior to and during treatment.
- To study the pre-treatment expression of various signaling molecules in the Src and STAT3 pathways and attempt to identify a relationship between these findings and the aggressiveness of the tumor or its response to treatment with dasatinib.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative and biological studies. Blood samples are analyzed for phosphorylation levels of proteins, including phospho-Src, phospho-Fak, and other relevant biomarkers, by western blotting. Tumor tissue samples are analyzed for biomarkers by immunohistochemistry.
Quality of life is assessed at baseline, after every other course during treatment, and then at 1 year after treatment using the FACT-HEP questionnaire.
After completion of study treatment, patients are followed every 2 months.
- Conditions
- Pancreatic Cancer
- Being tested
- dasatinib, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, quality-of-life assessment
- Keywords
- 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.
dasatinibDrug
immunoenzyme techniqueOther
laboratory biomarker analysisOther
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Experimental | Dasatinib 70 mg po bid (1 cycle=28 days) Receives: Drug: dasatinib; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Rate at 4 Months
Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).
Measured: Four months.
Secondary outcomes (1)
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: After every two cycles, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2012
Why it stopped: Toxicity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vincent Chung, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544908
- Sponsor's protocol ID
- 07024
- Other IDs
- P30CA033572, CHNMC-07024, BMS-CA180-114, CDR0000570288
- Status last verified
- Sep 2015
- First submitted
- 13 Oct 2007
- Last updated
- 5 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00544908
- Acronym / sponsor ID
- 07024
- Conditions
- Pancreatic Cancer
- Keywords
- stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Toxicity
- Enrolment
- 7 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2007
- Primary completion
- Oct 2012 (actual)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Posted 17 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with stage IV pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate the 4-month progression-free survival (PFS) rate in patients with stage IV pancreatic cancer treated with dasatinib.
Secondary
- To evaluate the response rate (complete and partial response) in patients treated with this drug.
- To evaluate the median PFS and overall survival of patients treated with this drug.
- To study the toxicities and tolerability of this drug in these patients.
- To evaluate the impact of this drug on quality of life measures.
- To evaluate the impact of this drug on Src and FAK in peripheral blood mononuclear cells prior to and during treatment.
- To study the pre-treatment expression of various signaling molecules in the Src and STAT3 pathways and attempt to identify a relationship between these findings and the aggressiveness of the tumor or its response to treatment with dasatinib.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative and biological studies. Blood samples are analyzed for phosphorylation levels of proteins, including phospho-Src, phospho-Fak, and other relevant biomarkers, by western blotting. Tumor tissue samples are analyzed for biomarkers by immunohistochemistry.
Quality of life is assessed at baseline, after every other course during treatment, and then at 1 year after treatment using the FACT-HEP questionnaire.
After completion of study treatment, patients are followed every 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Experimental | Drug: dasatinib, Other: immunoenzyme technique, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: quality-of-life assessmentDasatinib 70 mg po bid (1 cycle=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 |
|---|---|---|
| dasatinib | Drug | Dasatinib |
| immunoenzyme technique | Other | Dasatinib |
| immunohistochemistry staining method | Other | Dasatinib |
| laboratory biomarker analysis | Other | Dasatinib |
| quality-of-life assessment | Procedure or surgery | Dasatinib |
Primary outcome
Progression-free Survival (PFS) Rate at 4 Months
Time frame: Four months.
Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).
1 secondary outcome
Response Rate
Time frame: After every two cycles, up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vincent Chung, MD principal investigator
City of Hope Medical Center
2 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 dasatinib, immunoenzyme technique and immunohistochemistry staining method in people with Pancreatic Cancer, run by City of Hope Medical Center at 2 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: stopped early, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 17 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival (PFS) Rate at 4 Months (time frame: Four months.). 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 Oct 2015.