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Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery

This study has been terminated.
(Halted early for futility.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00459108
First Posted: April 11, 2007
Last Update Posted: March 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
This phase II trial is studying how well dasatinib works in treating patients with advanced liver cancer that cannot be removed by surgery. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition Intervention Phase
Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Drug: dasatinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Dasatinib (BMS-354825) in Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response Rate (Complete and Partial Response) [ Time Frame: 4 months ]
    Patients with confirmed partial or complete response using the RECIST criteria.

  • Four Month Progression-free Survival (PFS) [ Time Frame: 4 months ]
    Progression-free survival calculated using the method of Kaplan-Meier.


Secondary Outcome Measures:
  • Median PFS [ Time Frame: Up to 4 years ]
  • Overall Survival [ Time Frame: Up to 4 years ]
  • Safety and Tolerability [ Time Frame: Up to 4 years ]

Enrollment: 25
Study Start Date: April 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Dasatinib
Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: dasatinib
Given orally
Other Names:
  • BMS-354825
  • Sprycel

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the progression-free survival (PFS) rate and response rate (complete and partial response) at 4 months in patients with unresectable advanced hepatocellular carcinoma treated with dasatinib.

SECONDARY OBJECTIVES:

I. Determine the median PFS and overall survival of patients treated with this drug.

II. Assess the toxicity and tolerability of this drug in these patients.

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.

After completion of study treatment, patients are followed at 4 weeks and then every 3-6 months thereafter.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria:

  • WBC >= 3,000/mm^3
  • LVEF normal
  • Histologically or cytologically confirmed hepatocellular carcinoma; Advanced disease, unresectable disease, no Childs C criteria
  • Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
  • Not a candidate for percutaneous ethanol injection or radiofrequency ablation (RFA)
  • Prior transarterial chemoembolization, ethanol, and RFA allowed if new lesions are present in the liver and there are no other sites of disease
  • No pleural effusion or ascites requiring paracentesis within the past 4 weeks
  • No known brain metastases
  • ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Life expectancy > 3 months
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 75,000/mm^3
  • Bilirubin =< 2 times upper limit of normal (ULN)
  • AST and ALT =<2.5 times ULN (5 times ULN if liver involvement by tumor)
  • Creatinine =< 2 times ULN
  • PT =< 1.5 times ULN (no anticoagulation)
  • Albumin >= 2.5 mg/dL
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib
  • No evidence of encephalopathy
  • No condition that would preclude ability to swallow and retain dasatinib tablets, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication;
    • Requirement for IV alimentation;
    • Prior surgical procedures affecting absorption:
    • Active peptic ulcer disease
  • No clinically significant ECG abnormalities
  • No clinically significant cardiovascular disease, including any of the following:

    • Myocardial infarction or ventricular tachyarrhythmia within the past 6 months;
    • Prolonged QTc >= 480 msec (Fridericia correction);
    • Major conduction abnormality (unless cardiac pacemaker is present)
  • No other uncontrolled illness, including, but not limited to, any of the following:

    • Ongoing or active infection;
    • History of significant bleeding disorder, including congenital (von Willebrand's disease) or acquired disorders (antifactor VIII antibodies);
    • Psychiatric illness or social situation that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Recovered from all prior therapy
  • One prior systemic chemotherapy regimen allowed
  • Prior cryosurgery allowed
  • More than 4 weeks since prior transarterial chemoembolization
  • More than 4 weeks since prior radiotherapy
  • Prior or concurrent localized palliative radiotherapy (i.e., bony metastasis) allowed provided it was administered for =< 3 days
  • At least 7 days since prior and no concurrent antithrombotic and/or antiplatelet agents (e.g., warfarin, heparin, low molecular weight heparin, acetylsalicylic acid, and/or ibuprofen)
  • At least 7 days since prior and no concurrent agents with proarrhythmic potential
  • At least 7 days since prior and no concurrent medications or substances that are potent inhibitors or inducers of CYP3A4
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent embolization or chemoembolization
  • No concurrent systemic antacids (H2 receptor antagonists or proton pump inhibitors)
  • Locally active antacids allowed provided they are held for 2 hours before and 2 hours after dasatinib dose
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459108


Locations
United States, California
University of Southern California, Norris
Los Angeles, California, United States, 90033
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Heinz-Josef Lenz City of Hope Medical Center
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00459108     History of Changes
Other Study ID Numbers: NCI-2009-00224
NCI-2009-00224 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000538220
PHII-83
PHII-83 ( Other Identifier: City of Hope Medical Center )
7792 ( Other Identifier: CTEP )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
First Submitted: April 9, 2007
First Posted: April 11, 2007
Results First Submitted: June 19, 2014
Results First Posted: March 20, 2015
Last Update Posted: March 20, 2015
Last Verified: June 2014

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action