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Phase I/II Study of Gleevec (Imatinib Mesylate, Formerly Known as STI571) and Gemcitabine for Advanced Pancreas Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Phase I/II Study of Gleevec (Imatinib Mesylate, Formerly Known as STI571) and Gemcitabine for Advanced Pancreas 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine maximum tolerated dose according to toxicity

Outcome Time Frame:

After 1 cycle of therapy (1 cycle = 21 days)

Safety Issue:

Yes

Principal Investigator

Mary Mulcahy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 02I8

NCT ID:

NCT00281996

Start Date:

March 2005

Completion Date:

October 2008

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611