Imatinib Mesylate And Gemcitabine In Treating Patients With Locally Advanced, Metastatic, Or Recurrent Pancreatic Cancer

Study Overview

Imatinib Mesylate and Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Pancreatic Cancer

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving imatinib mesylate together with gemcitabine may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving imatinib mesylate together with gemcitabine and to see how well they work in treating patients with locally advanced, metastatic, or recurrent pancreatic cancer.

OBJECTIVES: Primary * Determine the maximum tolerated dose of imatinib mesylate and gemcitabine hydrochloride in patients with locally advanced, metastatic, or recurrent pancreatic cancer. * Determine the clinical response rate in patients treated with this regimen. * Determine the 6-month and overall survival of patients treated with this regimen. Secondary * Determine the toxicity profile of this regimen in these patients. * Correlate response with expression of platelet-derived growth factor (PDGF) and PDGF receptor in tumor tissue from patients treated with this regimen. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. * Phase I: Patients receive oral imatinib mesylate once daily on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8*. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of imatinib mesylate and gemcitabine hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 or 3 of 5 patients experience dose-limiting toxicity. NOTE: *The first cohort receives gemcitabine hydrochloride on days 1, 8, and 15 * Phase II: Patients receive imatinib mesylate and gemcitabine hydrochloride at the MTD determined in phase I in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Pancreatic Cancer

DRUG: Gemcitabine
DRUG: Imatinib mesylate

NU 02I8
NU-02I8
NU-0948-003

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 2006-01-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-08-24
First Submitted that Met QC Criteria 2006-01-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-08-26
First Posted (ESTIMATED) 2006-01-25	Results First Posted N/A	Last Verified 2011-08

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:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Determine maximum tolerated dose according to toxicity		After 1 cycle of therapy (1 cycle = 21 days)
Clinical response rate		After every 2 cycles of study therapy (1 cycle = 21 days)
Overall survival at 6 months		After 6 months of study treatment

Secondary Outcome Measures	Measure Description	Time Frame

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 confirmed pancreatic cancer

Locally advanced, metastatic, or recurrent disease
Measurable or evaluable disease by physical exam, plain radiographs, CT scan, or MRI
No brain metastases

ECOG performance status 0-2
Life expectancy of 12 weeks or greater
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
Creatinine ≤ 2.0 mg/dL
No chronic renal disease
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier-method contraception during and for ≥ 3 months after completion of study treatment
No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
No uncontrolled diabetes
No active uncontrolled infection
No other severe and/or uncontrolled medical disease
HIV negative

No prior therapy for metastatic disease

Prior fluorouracil as a radiosensitizer for adjuvant therapy after surgery or for locally advanced disease is permitted if local disease has recurred or progressed ≥ 3 months after completion of therapy or disease is present outside the radiation field
At least 2 weeks since prior major surgery
No concurrent grapefruit or grapefruit juice

Collaborators and Investigators

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

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Mary Mulcahy, MD, Robert H. Lurie Cancer Center

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

No publications available

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