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

Pancreatic Cancer Clinical Trial

Official title:

Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161213
• Other study ID #: CDR0000539409
• Secondary ID: P30CA072720CINJ-
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Est. completion date: October 2010

Study information

• Verified date: July 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• imatinib mesylate

Locations

Country	Name	City	State
United States	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	New Jersey
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Central Jersey Oncology Group	New Brunswick	New Jersey
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	New Jersey Medical School	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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