Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dasatinib

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)