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

NCT ID: NCT00161213

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2010-10-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine and Imatinib

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

imatinib mesylate

Intervention Type: DRUG

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

imatinib mesylate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth A. Poplin, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

CentraState Medical Center

Freehold, New Jersey, United States

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, United States

Jersey Shore Cancer Center at Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Central Jersey Oncology Group

New Brunswick, New Jersey, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

New Jersey Medical School

Newark, New Jersey, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22888387 (View on PubMed)

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CINJ-070501

Identifier Type: OTHER

Identifier Source: secondary_id

CINJ-5324

Identifier Type: OTHER

Identifier Source: secondary_id

CINJ-NJ1205

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000539409

Identifier Type: -

Identifier Source: org_study_id