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

September 8, 2005
November 21, 2012
September 2005
October 2010   (final data collection date for primary outcome measure)
Progression-free Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Progression-free survival in months.
Evaluate the time to progression for the novel combination of gemcitabine and imatinib mesylate for patients with chemotherapy-naïve metastatic pancreatic cancer.
Complete list of historical versions of study NCT00161213 on ClinicalTrials.gov Archive Site
  • 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 ]
-Assess the response rate and percent of patients who survive one year or more.
Not Provided
Not Provided
 
Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer
Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: imatinib mesylate
Experimental: Gemcitabine and Imatinib
Interventions:
  • Drug: gemcitabine hydrochloride
  • Drug: imatinib mesylate
Moss RA, Moore D, Mulcahy MF, Nahum K, Saraiya B, Eddy S, Kleber M, Poplin EA. A Multi-institutional Phase 2 Study of Imatinib Mesylate and Gemcitabine for First-Line Treatment of Advanced Pancreatic Cancer. Gastrointest Cancer Res. 2012 May;5(3):77-83.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
October 2010
October 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00161213
CDR0000539409, P30CA072720, CINJ-070501, CINJ-5324, CINJ-NJ1205
Yes
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Elizabeth A. Poplin, MD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP