Gemcitabine And Imatinib Mesylate As First-Line Therapy In Patients With Locally Adv. Or Metastatic Pancreatic Cancer

Study Overview

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

Pancreatic Cancer

DRUG: gemcitabine hydrochloride
DRUG: imatinib mesylate

CDR0000539409
P30CA072720 (U.S. NIH Grant/Contract)
CINJ-070501 (OTHER Identifier) (OTHER: CINJ)
CINJ-5324 (OTHER Identifier) (OTHER: CINJ)
CINJ-NJ1205 (OTHER Identifier) (OTHER: CINJ)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-09-08	Results First Submitted 2012-11-21	Last Update Submitted that met QC Criteria 2023-07-31
First Submitted that Met QC Criteria 2005-09-11	Results First Submitted that Met QC Criteria 2012-11-21	Last Update Posted (ACTUAL) 2023-08-14
First Posted (ACTUAL) 2005-09-12	Results First Posted 2012-12-27	Last Verified 2023-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gemcitabine and Imatinib	DRUG: gemcitabine hydrochloride DRUG: imatinib mesylate

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemcitabine and Imatinib

DRUG: gemcitabine hydrochloride

DRUG: imatinib mesylate

Primary Outcome Measures	Measure Description	Time Frame
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	4 years

Secondary Outcome Measures	Measure Description	Time Frame
Response Rate	Response rate as defined by a best response of "Stable Disease or better."	5 years
1-year Survival Rate	Percentage of subjects who survive up to 1 year	5 years
Overall Survival		5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Elizabeth A. Poplin, MD, Rutgers Cancer Institute of New Jersey

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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