Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00161213
First received: September 8, 2005
Last updated: November 21, 2012
Last verified: November 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Progression-free survival in months.


Secondary Outcome Measures:
  • Response Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Response rate as defined by a best response of "Stable Disease or better."

  • 1-year Survival Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Percentage of subjects who survive up to 1 year

  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: September 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine and Imatinib Drug: gemcitabine hydrochloride Drug: imatinib mesylate

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161213

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, New Jersey
CentraState Medical Center
Freehold, New Jersey, United States, 07728
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Jersey Shore Cancer Center at Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754
Central Jersey Oncology Group
New Brunswick, New Jersey, United States, 08901
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
New Jersey Medical School
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Elizabeth A. Poplin, MD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
Publications:
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00161213     History of Changes
Other Study ID Numbers: CDR0000539409, P30CA072720, CINJ-070501, CINJ-5324, CINJ-NJ1205
Study First Received: September 8, 2005
Results First Received: November 21, 2012
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
recurrent pancreatic cancer
stage IV pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage II pancreatic cancer

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

ClinicalTrials.gov processed this record on September 30, 2014