search
Back to results

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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
imatinib mesylate
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage IV pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage II pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • CentraState Medical Center
  • Cancer Institute of New Jersey at Hamilton
  • Jersey Shore Cancer Center at Jersey Shore University Medical Center
  • Central Jersey Oncology Group
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Saint Peter's University Hospital
  • New Jersey Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine and Imatinib

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival
Progression-free survival in months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Secondary Outcome Measures

Response Rate
Response rate as defined by a best response of "Stable Disease or better."
1-year Survival Rate
Percentage of subjects who survive up to 1 year
Overall Survival

Full Information

First Posted
September 8, 2005
Last Updated
July 31, 2023
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00161213
Brief Title
Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer
Official Title
Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
recurrent pancreatic cancer, stage IV pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage II pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine and Imatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival in months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Response Rate
Description
Response rate as defined by a best response of "Stable Disease or better."
Time Frame
5 years
Title
1-year Survival Rate
Description
Percentage of subjects who survive up to 1 year
Time Frame
5 years
Title
Overall Survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A. Poplin, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
CentraState Medical Center
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Jersey Shore Cancer Center at Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
Central Jersey Oncology Group
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22888387
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs