Clinical trial NCT00161213: Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer
Official title: Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer
stage IV pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage II pancreatic cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Progression-free Survival
timeFrame: 4 years
Secondary outcomes:
measure: Response Rate
timeFrame: 5 years
measure: 1-year Survival Rate
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Freehold
country: United States
facility: CentraState Medical Center
state: New Jersey
city: Hamilton
country: United States
facility: Cancer Institute of New Jersey at Hamilton
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore Cancer Center at Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Central Jersey Oncology Group
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Elizabeth A. Poplin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.