Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

NCT00544908 | Terminated Phase 2 Results

• 5 other identifiers: 07024P30CA033572CHNMC-07024BMS-CA180-114CDR0000570288
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer

Keywords

stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) Rate at 4 Months

  Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).

  Four months.

Secondary Outcomes (1)

• Response Rate

  After every two cycles, up to 5 years

Study Arms (1)

Dasatinib

EXPERIMENTAL

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

Drug: dasatinib; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment

Interventions

dasatinib DRUG

Dasatinib

immunoenzyme technique OTHER

Dasatinib

immunohistochemistry staining method OTHER

Dasatinib

laboratory biomarker analysis OTHER

Dasatinib

quality-of-life assessment PROCEDURE

Dasatinib

Eligibility Criteria

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

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)

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Dasatinib; Immunoenzyme Techniques; Immunohistochemistry

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Immunoassay; Immunologic Techniques; Investigative Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques

Limitations and Caveats

Study was terminated early due to toxicity.

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-256-4673

Study Officials

• Vincent Chung, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 13, 2007
• First Posted: October 16, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2012
• Last Updated: October 5, 2015
• Results First Posted: September 17, 2015

Record last verified: 2015-09

Locations

US (2)