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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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

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

Other trials in United States

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.

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.

Study groups in NCT00544908
Study groupRoleWhat they receive
DasatinibExperimentalDasatinib 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.

  1. 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)
  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.

  1. First posted16 Oct 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionOct 2012

Why it stopped: Toxicity

Resources

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)
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

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