A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
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.
Inclusion Criteria
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)
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival (PFS) at 4 months
Safety Issue:
No
Principal Investigator
Vincent Chung, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Federal Government
Study ID:
07024
NCT ID:
NCT00544908
Start Date:
September 2007
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| City of Hope Medical Group | Pasadena, California 91105 |
