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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of 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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Description:

Progression-free survival in months.

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Elizabeth A. Poplin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Institutional Review Board

Study ID:

CDR0000539409

NCT ID:

NCT00161213

Start Date:

September 2005

Completion Date:

October 2010

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage II pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

New Jersey Medical SchoolNewark, New Jersey  07103-2714
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Jersey Shore Cancer Center at Jersey Shore University Medical CenterNeptune, New Jersey  07754-0397
CentraState Medical CenterFreehold, New Jersey  07728
Central Jersey Oncology GroupNew Brunswick, New Jersey  08901