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

NCT01234935 | Completed Phase 2 DMC

• 2 other identifiers: TRIO-TORI PA-01NCI-2010-02190
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 17

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  At 18 months

Secondary Outcomes (2)

• Overall survival

  follow-up every 3 months for 30 months from first treatment or until disease recurrence or withdrawal of consent

• Disease-free survival

  at 18 months

Study Arms (2)

Arm I

EXPERIMENTAL

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.

Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Genetic: mutation analysis; Genetic: nucleic acid sequencing; Other: immunohistochemistry staining method

Arm II

EXPERIMENTAL

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.

Drug: dasatinib; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Genetic: mutation analysis; Genetic: nucleic acid sequencing; Other: immunohistochemistry staining method

Interventions

dasatinib DRUG

Given orally

Also known as: BMS-354825, Sprycel

Arm II

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, dFdCyd, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar, LY-188011

Arm I; Arm II

laboratory biomarker analysis OTHER

Correlative studies

Arm I; Arm II

mutation analysis GENETIC

Correlative studies

Arm I; Arm II

nucleic acid sequencing GENETIC

Correlative studies

Also known as: Gene Sequencing, Molecular Biology, Nucleic Acid Sequencing

Arm I; Arm II

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Oncology Research International: lead

Study Sites (17)

Central Hematology Oncology Medical Group, Inc.

Alhambra, California, 91801, United States

Location

TORI FULLERTON (St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center)

Fullerton, California, 92835, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

UCLA medical center

Los Angeles, California, 90024-3417, United States

Location

Translational Oncology Research International (TORI) Network

Los Angeles, California, 90095, United States

Location

TORI NORTHRIDGE (North Valley Hematology/Oncology Medical Group)

Northridge, California, 91325, United States

Location

UCLA Pasadena

Pasadena, California, United States

Location

TORI Inland Valley (Wilshire Oncology Medical Group, Inc. )

Pomona, California, 91767, United States

Location

TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.)

Redondo Beach, California, 90277, United States

Location

TORI SANTA BARBARA I (Santa Barbara Hematology Oncology Medical Group, Inc.)

Santa Barbara, California, 93105, United States

Location

TORI SANTA BARBARA II (SANSUM Clinic)

Santa Barbara, California, 93105, United States

Location

TORI SANTA MARIA (Central Coast Medical Oncology Corporation)

Santa Maria, California, 93454, United States

Location

UCLA Valencia

Valencia, California, United States

Location

Suburban Hematology-Oncology Associates, P.A.

Lawrenceville, Georgia, 30045, United States

Location

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, 30060, United States

Location

Chevy Chase Healthcare Management, LLC

Chevy Chase, Maryland, 20815, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Dasatinib; Gemcitabine; Base Sequence; Immunohistochemistry

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Richard Finn

  Translational Oncology Research International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 4, 2010
• Study Start: January 13, 2011
• Primary Completion: November 27, 2017
• Study Completion: November 27, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (17)