Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

NCT ID: NCT00544908

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30

Brief Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with stage IV pancreatic cancer.

Detailed Description

OBJECTIVES:

Primary

• To evaluate the 4-month progression-free survival (PFS) rate in patients with stage IV pancreatic cancer treated with dasatinib.

Secondary

• To evaluate the response rate (complete and partial response) in patients treated with this drug.
• To evaluate the median PFS and overall survival of patients treated with this drug.
• To study the toxicities and tolerability of this drug in these patients.
• To evaluate the impact of this drug on quality of life measures.
• To evaluate the impact of this drug on Src and FAK in peripheral blood mononuclear cells prior to and during treatment.
• To study the pre-treatment expression of various signaling molecules in the Src and STAT3 pathways and attempt to identify a relationship between these findings and the aggressiveness of the tumor or its response to treatment with dasatinib.

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.

Patients undergo tumor tissue and blood sample collection periodically for correlative and biological studies. Blood samples are analyzed for phosphorylation levels of proteins, including phospho-Src, phospho-Fak, and other relevant biomarkers, by western blotting. Tumor tissue samples are analyzed for biomarkers by immunohistochemistry.

Quality of life is assessed at baseline, after every other course during treatment, and then at 1 year after treatment using the FACT-HEP questionnaire.

After completion of study treatment, patients are followed every 2 months.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dasatinib

Dasatinib 70 mg po bid (1 cycle=28 days)

Group Type: EXPERIMENTAL

dasatinib

Intervention Type: DRUG

immunoenzyme technique

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

quality-of-life assessment

Intervention Type: PROCEDURE

Interventions

dasatinib

Intervention Type: DRUG

immunoenzyme technique

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically* confirmed pancreatic cancer

• Stage IV disease NOTE: *If biopsy was performed at an outside facility, the histology must be reviewed and confirmed by the Division of Pathology at the City of Hope

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Life expectancy ≥ 3 months
• Platelet count ≥ 100,000/μL
• Absolute neutrophil count ≥ 1,500/μL
• Bilirubin ≤ 1.5 mg/dL
• ALT and AST ≤ 2.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 mg/dL and/or creatinine clearance > 60 mL/min
• PT and PTT ≤ 1.5 times ULN
• Able to swallow dasatinib whole
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
• No concurrent medical condition which may increase the risk of toxicity, including any of the following:

• Pleural or pericardial effusion of any grade
• Clinically significant coagulation or platelet function disorder (e.g., known von Willebrand's disease)
• None of the following cardiac conditions:

• Uncontrolled angina, congestive heart failure, or myocardial infarction within the past 6 months
• Prolonged QTc interval (i.e., QTc > 450 msec) on electrocardiogram
• History of clinically significant ventricular arrhythmias (i.e., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
• No hypokalemia or hypomagnesemia that cannot be corrected
• No severe infection requiring treatment
• Completely recovered from other concurrent illnesses, as deemed by the investigator
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• Recovered from prior major surgery
• No prior irradiation to the planned field
• No prior chemotherapy for pancreatic cancer
• At least 7 days since prior and no concurrent medications that may prolong the QT interval, including any of the following:

• Quinidine
• Procainamide
• Disopyramide
• Amiodarone
• Sotalol
• Ibutilide
• Dofetilide
• Erythromycin
• Clarithromycin
• Chlorpromazine
• Haloperidol
• Mesoridazine
• Thioridazine
• Pimozide
• Cisapride
• Bepridil
• Droperidol
• Methadone
• Arsenic
• Chloroquine
• Domperidone
• Halofantrine
• Levomethadyl
• Pentamidine
• Sparfloxacin
• Lidoflazine
• At least 7 days since prior and no concurrent potent CYP3A4 inhibitors
• At least 7 days since prior and no concurrent medications that directly and durably inhibit platelet function, including any of the following:

• Aspirin or aspirin-containing combinations
• Clopidogrel
• Dipyridamole
• Tirofiban
• Dipyridamole
• Epoprostenol
• Eptifibatide
• Cilostazol
• Abciximab
• Ticlopidine
• Cilostazol
• No concurrent anticoagulants, including warfarin or heparin/low molecular weight heparin (e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin)

• Low-dose warfarin for prophylaxis to prevent catheter thrombosis or heparin for flushes of IV lines allowed
• No concurrent IV bisphosphonates during the first 8 weeks of dasatinib therapy
• No concurrent Hypericum perforatum (St. Johns wort)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Chung, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope Medical Group

Pasadena, California, United States

Countries

United States

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-07024

Identifier Type: -

Identifier Source: secondary_id

BMS-CA180-114

Identifier Type: -

Identifier Source: secondary_id

CDR0000570288

Identifier Type: REGISTRY

Identifier Source: secondary_id

07024

Identifier Type: -

Identifier Source: org_study_id