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Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dasatinib
immunoenzyme technique
immunohistochemistry staining method
laboratory biomarker analysis
quality-of-life assessment
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • City of Hope Medical Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dasatinib

Arm Description

Dasatinib 70 mg po bid (1 cycle=28 days)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2007
Last Updated
September 18, 2015
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00544908
Brief Title
Dasatinib in Treating Patients With Stage IV Pancreatic Cancer
Official Title
A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Toxicity
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dasatinib
Arm Type
Experimental
Arm Description
Dasatinib 70 mg po bid (1 cycle=28 days)
Intervention Type
Drug
Intervention Name(s)
dasatinib
Intervention Type
Other
Intervention Name(s)
immunoenzyme technique
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) Rate at 4 Months
Description
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).
Time Frame
Four months.
Secondary Outcome Measure Information:
Title
Response Rate
Description
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
Time Frame
After every two cycles, up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Chung, MD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
City of Hope Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

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