Phase II Study of Fixed Dose Rate Gemcitabine Plus Capecitabine in Locally Advanced Pancreatic Cancer
Inclusion Criteria:
- Histologically or cytologically documented pancreatic adenocarcinoma
- Clinical T3 or T4 tumor according to AJCC staging system
- Tumors considered as borderline resectable or unresectable disease assessed by
multidisciplinary team including pancreatic surgeon, gastroenterologist specializing
in pancreas, medical oncologist, and radiation oncologist
- Age 18 years or older
- ECOG performance status 2 or less
- Adequate organ function
- Adequate bone marrow function (WBCs> 3,500/µL, absolute neutrophil count [ANC]>
1,500/µL, hemoglobin > 9.0 g/dL, and platelets > 100,000/µL)
- Adequate kidney function (creatinine < 1.5 mg/dL)
- Adequate liver function (bilirubin < 1.5 mg/dL [<2.5 mg/dL for patients with
obstructive jaundice due to pancreatic cancer with adequate decompression],
transaminases levels < 3 times the upper normal limit)
- Patients must not have psychological, familial, sociological or geographical
conditions which do not permit medical follow-up and compliance with this study
- Women of childbearing potential must have a negative pregnancy test on admission.
Post-menopausal women must have been amenorrheic for at least 12 months to be
considered of non-childbearing potential. Men and women of reproductive potential
must have agreed to use an effective method of contraception while on treatment and
for 6 months after study treatment
- The patient must be able to understand the study and has given written informed
consent to participate in the study
Exclusion Criteria:
- Other tumor type than adenocarcinoma
- Evidence of gastrointestinal bleeding or obstruction
- Presence of the clinically relevant ascites or distant metastases
- Past or concurrent history of malignant neoplasm, except for curatively treated
non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate
contraception
- Hypersensitivity to any of the study drugs or ingredients
- Other serious illness or medical conditions
- Unstable cardiac disease despite treatment, myocardial infarction within 6
months prior to study entry
- History of significant neurologic or psychiatric disorders including dementia or
seizures
- Active uncontrolled infection
- Pre-existing clinically significant diarrhea
- Active peptic ulcer
- Severe hypercalcemia of 12 mg/dL uncontrolled with bisphosphonates
- Active disseminated intravascular coagulation
- Other serious underlying medical conditions which could impair the ability of
the patient to participate in the study
- Concomitant or administration of any other experimental drug under investigation
within 3 weeks before the study
- Concomitant chemotherapy, hormonal therapy, or immunotherapy