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Dasatinib and Gemcitabine Hydrochloride or Gemcitabine Hydrochloride Alone in Treating Patients With Pancreatic Cancer Previously Treated With Surgery

Primary Purpose

Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dasatinib
gemcitabine hydrochloride
laboratory biomarker analysis
mutation analysis
nucleic acid sequencing
immunohistochemistry staining method
Sponsored by
Translational Oncology Research International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acinar Cell Adenocarcinoma of the Pancreas

Eligibility Criteria

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

Inclusion Criteria:

  • Written informed consent before beginning any protocol specified procedures
  • Histologically proven pancreatic adenocarcinoma
  • Any T, any N, M0 disease that has had all gross disease resected (R0 or R1 resection)
  • ECOG Performance status index 0 or 1
  • Absolute Neutrophils >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Hemoglobin >= 10 g/dL
  • Total bilirubin =< 2.0 x UNL; subjects with Gilbert's syndrome, confirmed by genotyping or invader UGTIA1 molecular assay before study entry must have total bilirubin < 3 x UNL
  • ASAT (SGOT) and ALAT (SGPT) =< 2.5 x UNL
  • Alkaline Phosphatase =< 5 x UNL
  • Creatinine < 1.5 x UNL
  • Serum Na, K+, Magnesium, Phosphate and Calcium >= LNL
  • First study treatment must be given within 60 days after surgery and within 7 days after randomization
  • Patients must be accessible for treatment and follow-up and compliant with study procedures
  • Negative pregnancy test (urine or serum) within 7 days before first study treatment for all women of childbearing potential, whom also must implement adequate non-hormonal contraceptive measures during study treatment and for at least 3 months after the last dose of study therapy
  • Ability to take oral medication (dasatinib must be swallowed whole)

Exclusion Criteria:

  • Prior or concurrent systemic anticancer therapy (immunotherapy, hormonal therapy, biological therapy, or chemotherapy) for pancreatic cancer
  • Prior or concurrent radiation therapy for pancreatic cancer
  • Pregnant or lactating patients
  • M1 pancreatic cancer
  • Concurrent congestive heart failure, unstable angina pectoris, or M1 within the 6 months before first study treatment
  • Uncontrolled hypertension or high-risk uncontrolled arrhythmias
  • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
  • Diagnosed or suspected congenital long QT syndrome
  • Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
  • History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
  • Past or current history of neoplasm other than pancreatic adenocarcinoma, except for: curatively treated non-melanoma skin cancer; in situ carcinoma of the cervix; other cancer curatively treated and with no evidences of disease for at least 1 year
  • Concurrent treatment with other experimental drugs or treatment with investigational drugs within 30 days of first study treatment
  • Currently receiving drugs with known significant CYP 3A4 inhibitory effects (such as ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil, ritonavir, indinavir)
  • Concurrent administration with inducers of CYP 3A4 may result in a lower exposure to dasatinib and are therefore not allowed (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital, pentobarbital, or St John's Wort)
  • Known allergy reactions to dasatinib or gemcitabine or excipients used in the study
  • History of significant bleeding disorders unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., Von Willebrand's disease); diagnosed acquired bleeding disorder within 1 year (e.g., acquired anti-factor VIII antibodies); ongoing or recent (=< 3 months) significant gastrointestinal bleeding
  • Patients currently taking drugs that are generally accepted to have a risk of causing Torsades De Pointes including: quinidine, procainamide, disopyramide; amiodarone, sotalol, ibutilide, dofetilide; erythromycins, clarithromycin; chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide; cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
  • Concurrent treatment with intravenous bisphosphonates; prior treatment should be stopped at least 2 weeks before first dose of study treatment
  • Concurrent medical condition which may increase the risk of toxicity, including pleural or pericardial effusion or any grade
  • Active uncontrolled infection requiring parenteral antimicrobials

Sites / Locations

  • Central Hematology Oncology Medical Group, Inc.
  • TORI FULLERTON (St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center)
  • Pacific Shores Medical Group
  • UCLA medical center
  • Translational Oncology Research International (TORI) Network
  • TORI NORTHRIDGE (North Valley Hematology/Oncology Medical Group)
  • UCLA Pasadena
  • TORI Inland Valley (Wilshire Oncology Medical Group, Inc. )
  • TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.)
  • TORI SANTA BARBARA I (Santa Barbara Hematology Oncology Medical Group, Inc.)
  • TORI SANTA BARBARA II (SANSUM Clinic)
  • TORI SANTA MARIA (Central Coast Medical Oncology Corporation)
  • UCLA Valencia
  • Suburban Hematology-Oncology Associates, P.A.
  • Northwest Georgia Oncology Centers, P.C.
  • Chevy Chase Healthcare Management, LLC
  • Comprehensive Cancer Centers of Nevada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral dasatinib once daily on days 1-28. Treatment repeats every 28 days for 6 courses* in the absence of disease progression or unacceptable toxicity. NOTE: *Courses with dasatinib repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Overall survival
Disease-free survival

Full Information

First Posted
November 1, 2010
Last Updated
January 5, 2018
Sponsor
Translational Oncology Research International
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1. Study Identification

Unique Protocol Identification Number
NCT01234935
Brief Title
Dasatinib and Gemcitabine Hydrochloride or Gemcitabine Hydrochloride Alone in Treating Patients With Pancreatic Cancer Previously Treated With Surgery
Official Title
A Multicenter, Open-Label, Randomized, Phase II Trial of Adjuvant Dasatinib Plus Gemcitabine Versus Single-Agent Gemcitabine in Patients With Resected Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 13, 2011 (Actual)
Primary Completion Date
November 27, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Oncology Research International

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving dasatinib together with gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating pancreatic cancer. PURPOSE: This randomized phase II trial is studying how well giving dasatinib together with gemcitabine hydrochloride works compared to giving gemcitabine hydrochloride alone in treating patients with pancreatic cancer previously treated with surgery.
Detailed Description
PRIMARY OBJECTIVES: I. To compare disease-free survival at 18 months between dasatinib-gemcitabine combination therapy and single-agent gemcitabine. SECONDARY OBJECTIVES: I. To evaluate effects on disease-free survival of the dasatinib-gemcitabine combination therapy compared with gemcitabine alone for adjuvant treatment of resected pancreatic adenocarcinoma. II. To evaluate effects on overall survival of dasatinib-gemcitabine combination therapy compared with gemcitabine alone for adjuvant treatment of resected pancreatic adenocarcinoma. III. To evaluate tolerability and safety of the two arms. IV. To identify potential biological correlates associated with clinical benefit to dasatinib-gemcitabine combination therapy compared with gemcitabine alone. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral dasatinib once daily on days 1-28. Treatment repeats every 28 days for 6 courses* in the absence of disease progression or unacceptable toxicity. NOTE: * Courses with dasatinib repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral dasatinib once daily on days 1-28. Treatment repeats every 28 days for 6 courses* in the absence of disease progression or unacceptable toxicity. NOTE: *Courses with dasatinib repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
dasatinib
Other Intervention Name(s)
BMS-354825, Sprycel
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
dFdC, dFdCyd, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar, LY-188011
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Description
Correlative studies
Intervention Type
Genetic
Intervention Name(s)
nucleic acid sequencing
Other Intervention Name(s)
Gene Sequencing, Molecular Biology, Nucleic Acid Sequencing
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Other Intervention Name(s)
immunohistochemistry
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
At 18 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
follow-up every 3 months for 30 months from first treatment or until disease recurrence or withdrawal of consent
Title
Disease-free survival
Time Frame
at 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent before beginning any protocol specified procedures Histologically proven pancreatic adenocarcinoma Any T, any N, M0 disease that has had all gross disease resected (R0 or R1 resection) ECOG Performance status index 0 or 1 Absolute Neutrophils >= 1.5 x 10^9/L Platelets >= 100 x 10^9/L Hemoglobin >= 10 g/dL Total bilirubin =< 2.0 x UNL; subjects with Gilbert's syndrome, confirmed by genotyping or invader UGTIA1 molecular assay before study entry must have total bilirubin < 3 x UNL ASAT (SGOT) and ALAT (SGPT) =< 2.5 x UNL Alkaline Phosphatase =< 5 x UNL Creatinine < 1.5 x UNL Serum Na, K+, Magnesium, Phosphate and Calcium >= LNL First study treatment must be given within 60 days after surgery and within 7 days after randomization Patients must be accessible for treatment and follow-up and compliant with study procedures Negative pregnancy test (urine or serum) within 7 days before first study treatment for all women of childbearing potential, whom also must implement adequate non-hormonal contraceptive measures during study treatment and for at least 3 months after the last dose of study therapy Ability to take oral medication (dasatinib must be swallowed whole) Exclusion Criteria: Prior or concurrent systemic anticancer therapy (immunotherapy, hormonal therapy, biological therapy, or chemotherapy) for pancreatic cancer Prior or concurrent radiation therapy for pancreatic cancer Pregnant or lactating patients M1 pancreatic cancer Concurrent congestive heart failure, unstable angina pectoris, or M1 within the 6 months before first study treatment Uncontrolled hypertension or high-risk uncontrolled arrhythmias Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes) Diagnosed or suspected congenital long QT syndrome Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent Past or current history of neoplasm other than pancreatic adenocarcinoma, except for: curatively treated non-melanoma skin cancer; in situ carcinoma of the cervix; other cancer curatively treated and with no evidences of disease for at least 1 year Concurrent treatment with other experimental drugs or treatment with investigational drugs within 30 days of first study treatment Currently receiving drugs with known significant CYP 3A4 inhibitory effects (such as ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil, ritonavir, indinavir) Concurrent administration with inducers of CYP 3A4 may result in a lower exposure to dasatinib and are therefore not allowed (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital, pentobarbital, or St John's Wort) Known allergy reactions to dasatinib or gemcitabine or excipients used in the study History of significant bleeding disorders unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., Von Willebrand's disease); diagnosed acquired bleeding disorder within 1 year (e.g., acquired anti-factor VIII antibodies); ongoing or recent (=< 3 months) significant gastrointestinal bleeding Patients currently taking drugs that are generally accepted to have a risk of causing Torsades De Pointes including: quinidine, procainamide, disopyramide; amiodarone, sotalol, ibutilide, dofetilide; erythromycins, clarithromycin; chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide; cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine Concurrent treatment with intravenous bisphosphonates; prior treatment should be stopped at least 2 weeks before first dose of study treatment Concurrent medical condition which may increase the risk of toxicity, including pleural or pericardial effusion or any grade Active uncontrolled infection requiring parenteral antimicrobials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Finn
Organizational Affiliation
Translational Oncology Research International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Hematology Oncology Medical Group, Inc.
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
TORI FULLERTON (St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
UCLA medical center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024-3417
Country
United States
Facility Name
Translational Oncology Research International (TORI) Network
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
TORI NORTHRIDGE (North Valley Hematology/Oncology Medical Group)
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
UCLA Pasadena
City
Pasadena
State/Province
California
Country
United States
Facility Name
TORI Inland Valley (Wilshire Oncology Medical Group, Inc. )
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.)
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
TORI SANTA BARBARA I (Santa Barbara Hematology Oncology Medical Group, Inc.)
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
TORI SANTA BARBARA II (SANSUM Clinic)
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
TORI SANTA MARIA (Central Coast Medical Oncology Corporation)
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
UCLA Valencia
City
Valencia
State/Province
California
Country
United States
Facility Name
Suburban Hematology-Oncology Associates, P.A.
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Northwest Georgia Oncology Centers, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Chevy Chase Healthcare Management, LLC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dasatinib and Gemcitabine Hydrochloride or Gemcitabine Hydrochloride Alone in Treating Patients With Pancreatic Cancer Previously Treated With Surgery

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