Know Cancer

or
forgot password

A Multicenter, Open-Label, Randomized, Phase II Trial of Adjuvant Dasatinib Plus Gemcitabine Versus Single-Agent Gemcitabine in Patients With Resected Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acinar Cell Carcinoma of Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Pancreatic Carcinoma Recurrent, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Pancreatic Carcinoma Stage III

Thank you

Trial Information

A Multicenter, Open-Label, Randomized, Phase II Trial of Adjuvant Dasatinib Plus Gemcitabine Versus Single-Agent Gemcitabine in Patients With Resected Pancreatic Adenocarcinoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

At 18 months

Safety Issue:

No

Principal Investigator

Richard Finn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Translational Oncology Research International

Authority:

United States: Food and Drug Administration

Study ID:

TRIO-TORI PA-01

NCT ID:

NCT01234935

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Acinar Cell Carcinoma of Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Pancreatic Carcinoma Recurrent
  • Stage IA Pancreatic Cancer
  • Stage IB Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Pancreatic Cancer
  • Pancreatic Carcinoma Stage III
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Pancreatic Neoplasms
  • Carcinoma, Acinar Cell

Name

Location

Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Pacific Shores Medical GroupLong Beach, California  90813
UCLA Medical CenterLos Angeles, California  90095-7059
Northwest Georgia Oncology Centers, P.C.Marietta, Georgia  30060
Central Hematology Oncology Medical Group, Inc.Alhambra, California  91801
Suburban Hematology-Oncology Associates, P.A.Lawrenceville, Georgia  30045
Translational Oncology Research International (TORI) NetworkLos Angeles, California  90095
Chevy Chase Healthcare Management, LLCChevy Chase, Maryland  20815
TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.)Redondo Beach, California  90277
TORI FULLERTON (St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center)Fullerton, California  92835
TORI NORTHRIDGE (North Valley Hematology/Oncology Medical Group)Northridge, California  91325
UCLA PasadenaPasadena, California  
TORI Inland Valley (Wilshire Oncology Medical Group, Inc. )Pomona, California  91767
TORI SANTA BARBARA I (Santa Barbara Hematology Oncology Medical Group, Inc.)Santa Barbara, California  93105
TORI SANTA BARBARA II (SANSUM Clinic)Santa Barbara, California  93105
TORI SANTA MARIA (Central Coast Medical Oncology Corporation)Santa Maria, California  93454
UCLA ValenciaValencia, California