The patient will take four pills each morning of imatinib (Gleevec) for five (5) days, usually Monday through Friday, every week for two (2) weeks of every three (3). On Day 3 (the third day) and Day 10 (the tenth day) of each of these same two weeks, the patient will receive the drug gemcitabine (Gemzar). This will be given in the doctor’s office or the clinic. It will be given into a vein (IV: intravenous) using a small needle or plastic tube. During the third week, the patient will receive no drug – no imatinib (Gleevec) or gemcitabine (Gemzar). This three (3) week period is known as a cycle. The three week cycle of imatinib (Gleevec) pills and IV gemcitabine (Gemzar) in the first two weeks followed by one week of rest will be repeated for as long as the tumor shrinks (becomes smaller) or remains the same.For as long as the patient is receiving the above treatment, he/she will need to have blood tests done every week. The amount is equal to one to three teaspoons. The blood will be checked to see if the patient is having any side effects from the treatment.Each patient will also need to have a CAT scan or a MRI scan prior to treatment and then repeated after every nine weeks. This will be done to see how the tumors are responding to treatment. Also each patient will be asked to complete forms with questions on them asking about how he/she is feeling. This will be done every nine weeks for about six months.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: Imatinib Mesylate and Gemcitabine	Phase II

Further Study Details: 

Primary Outcomes: Evaluate the time to progression for the novel combination of gemcitabine and imatinib mesylate for patients with chemotherapy-naïve metastatic pancreatic cancer.
Secondary Outcomes: -Assess the response rate and percent of patients who survive one year or more.
Expected Total Enrollment:  28

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion:

Patients must have either histologically or cytologically confirmed evidence of pancreatic adenocarcinoma or poorly differentiated carcinoma (originating in the pancreas) that is locally advanced or metastatic.

• the patient must not be eligible for curative resection.
• Patients must have measurable and/or non-measurable (evaluable) disease as defined by RECIST criteria. Baseline measurements must be obtained within 4 weeks prior to registration. CA 19-9 elevation as the only evidence of disease will be insufficient for eligibility.
• patients must have had no prior chemotherapy for metastatic disease. The use of flourouracil as a radiosensitizing agent is allowed.
• Patients with prior surgical resection and history of adjuvant fluorouracil chemotherapy are eligible providing that there was an interval of > 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer.
• Patients may not have received prior gemcitabine or prior imatinib.
• Patients with a history of prior radiotherapy are eligible with the following parameters:
• Patients must be 4 weeks post-therapy and have recovered from all toxicities.
• Patients must have evidence of disease outside the radiation fields or radiologically confirmed progression of disease within the radiation fields after radiation was completed.
• Patients must have an ECOG performance status 2 or less
• Patients must have adequate organ and marrow function
• Age 18 years+
• Patients must give signed written informed consent prior to registration on study.
• Women of child-bearing potential and sexually active men must agree to use adequate methods of contraception for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Adequate methods of contraception include barrier method(s) of birth control; abstinence; tubal ligation for women or vasectomy for men. Since this is a type cancer with a high risk of patients developing blood clots, it is recommended that while on-study women do not use hormonal birth control.

Exclusion Criteria

• A patient will not be eligible for this study if any of the following exclusion criteria are met.
• Any coexisting medical condition or medications precluding compliance with the study.
• Inability to ingest tablets.
• Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Patients receiving therapeutic warfarin therapy (mini-dose [£ 1 mg daily] allowed to maintain catheter patency as is allowed in other imatinib protocols), or chronic systemic corticosteroids.
• Patients with chronic uncontrolled diarrhea and/or daily emesis.

Please refer to this study by ClinicalTrials.gov identifier  NCT00161213

Eizabeth Poplin, MD      732-235-8053    poplinea@umdnj.edu

New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08901,  United States; Recruiting

Study chairs or principal investigators

Elizabeth Poplin, MD,  Principal Investigator,  University of Medicine and Dentistry New Jersey   

Study ID Numbers:  5324; CINJ# 070501
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161213
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13