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Gemcitabine and Imatinib Mesylate as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00161213
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works as first-line therapy in treating patients with locally advanced or metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: gemcitabine hydrochloride
Drug: imatinib mesylate
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Imatinib Imatinib mesylate Pancrelipase Ultrase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled
Official Title: Phase II Study of Imatinib Mesylate and Gemcitabine for First-Line Treatment of Metastatic Pancreatic Cancer

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

Primary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Percentage of patients who survive 1 year or more [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: February 2005
Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the time to progression in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and imatinib mesylate as first-line therapy.

Secondary

  • Assess the response rate in patients treated with this regimen.
  • Assess the percentage of patients treated with this regimen who survive 1 year or more.
  • Assess the toxicity of this regimen in these patients.
  • Assess the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter, nonrandomized, open-label, uncontrolled study.

Patients receive gemcitabine hydrochloride IV over 120 minutes on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma (originating in the pancreas)

    • Locally advanced or metastatic disease
  • Not eligible for curative resection
  • Must have measurable or evaluable disease as defined by RECIST criteria

    • No CA19-9 elevation as only evidence of disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 125,000/mm³
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase < 3 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No coexisting medical condition that would preclude study compliance
  • No inability to ingest tablets
  • No active illness (e.g., active or uncontrolled infection, uncontrolled cardiac disease) that would preclude study participation
  • No chronic uncontrolled diarrhea and/or daily emesis
  • No other cancer within the past 5 years except for surgically removed noninvasive nonmelanoma skin cancer or in situ cervical cancer

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for metastatic disease
  • No prior gemcitabine
  • No prior imatinib mesylate
  • Prior surgical resection and adjuvant fluorouracil chemotherapy allowed provided there was an interval of > 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer
  • Prior fluorouracil as a radiosensitizing agent allowed
  • At least 4 weeks since prior radiotherapy and recovered

    • Must have evidence of disease outside the radiation fields OR radiologically confirmed disease progression within the radiation fields after completion of radiotherapy
  • No concurrent therapeutic warfarin

    • Prophylactic warfarin ≤ 1 mg daily allowed for prophylaxis of central venous catheter thrombosis
    • Low molecular weight heparin or heparin allowed for anticoagulation
  • No concurrent chronic systemic corticosteroids
  • No other concurrent agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, or cancer surgery
  • No other concurrent experimental medications
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161213

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
United States, New Jersey
Cancer Institute of New Jersey at Hamilton Recruiting
Hamilton, New Jersey, United States, 08690
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham     609-631-6946        
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey     732-235-8675        
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Contact Person     732-745-8600        
Jersey Shore Cancer Center at Jersey Shore University Medical Center Recruiting
Neptune, New Jersey, United States, 07754
Contact: Contact Person     732-776-4240        
CentraState Medical Center Recruiting
Freehold, New Jersey, United States, 07728
Contact: Contact Person     732-431-2000        
Sponsors and Collaborators
Cancer Institute of New Jersey
Investigators
Principal Investigator: Elizabeth A. Poplin, MD Cancer Institute of New Jersey
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000539409, CINJ-070501, CINJ-5324, CINJ-NJ1205
Study First Received: September 8, 2005
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00161213  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage IV pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage II pancreatic cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Recurrence
Imatinib
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009