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

NCT00459108 | Terminated Phase 2 Results

• 6 other identifiers: NCI-2009-00224CDR0000538220PHII-837792N01CM62201N01CM62209
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (2)

• Response Rate (Complete and Partial Response)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR

  4 months

• Four Month Progression-free Survival (PFS)

  Progression-free survival calculated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  4 months

Secondary Outcomes (3)

• Median Progression-free Survival

  Until disease progression or death, up to 4 years

• Overall Survival

  Up to 4 years

• Safety and Tolerability

  Up to 4 years

Study Arms (1)

Oral Dasatinib

EXPERIMENTAL

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

Interventions

dasatinib DRUG

Given orally

Also known as: BMS-354825, Sprycel

Oral Dasatinib

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Southern California, Norris

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results.

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Heinz-Josef Lenz

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: April 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 19, 2018
• Results First Posted: March 20, 2015

Record last verified: 2018-03

Locations

US (1)