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Acinar Cell Adenocarcinoma of the PancreasPhase 2NCT01234935

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

A Phase 2 study testing dasatinib, gemcitabine hydrochloride and laboratory biomarker analysis in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by Translational Oncology Research International at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
dasatinib, gemcitabine hydrochloride and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
17 sitesUnited States
Study dates
13 Jan 2011to 27 Nov 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Central Hematology Oncology Medical Group, Inc.

    Alhambra, California, 91801

  • Chevy Chase Healthcare Management, LLC

    Chevy Chase, Maryland, 20815

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

    Fullerton, California, 92835

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Suburban Hematology-Oncology Associates, P.A.

    Lawrenceville, Georgia, 30045

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • UCLA medical center

    Los Angeles, California, 90024-3417

  • Translational Oncology Research International (TORI) Network

    Los Angeles, California, 90095

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • TORI NORTHRIDGE (North Valley Hematology/Oncology Medical Group)

    Northridge, California, 91325

  • UCLA Pasadena

    Pasadena, California

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

    Pomona, California, 91767

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

    Redondo Beach, California, 90277

  • 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 Valencia

    Valencia, California

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
dasatinib, gemcitabine hydrochloride, laboratory biomarker analysis, mutation analysis, nucleic acid sequencing
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dasatinibDrug

    Also called BMS-354825, Sprycel

    Given orally

  • gemcitabine hydrochlorideDrug

    Also called dFdC, dFdCyd, difluorodeoxycytidine hydrochloride, gemcitabine

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • mutation analysisGenetic

    Correlative studies

  • nucleic acid sequencingGenetic

    Also called Gene Sequencing, Molecular Biology, Nucleic Acid Sequencing

    Correlative studies

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Correlative studies

Study groups in NCT01234935
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Genetic: mutation analysis; Genetic: nucleic acid sequencing; Other: immunohistochemistry staining method
Arm IIExperimentalPatients 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.
Receives: Drug: dasatinib; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Genetic: mutation analysis; Genetic: nucleic acid sequencing; Other: immunohistochemistry staining method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    Measured: At 18 months

Secondary outcomes (2)

  1. Overall survival

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

  2. Disease-free survival

    Measured: at 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2010 (estimated)
  2. Study start13 Jan 2011
  3. Primary completion27 Nov 2017
  4. Study completion27 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01234935
Sponsor's protocol ID
TRIO-TORI PA-01
Other IDs
NCI-2010-02190
Status last verified
Jan 2018
First submitted
1 Nov 2010
Last updated
9 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dasatinib, gemcitabine hydrochloride and laboratory biomarker analysis in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by Translational Oncology Research International at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: At 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01234935.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.

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