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Phase II Study of Fixed Dose Rate Gemcitabine Plus Capecitabine in Locally Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

R0 resection rate

Outcome Description:

Microscopic complete resection rate after neoadjuvant chemotherapy

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jae-Lyun Lee, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

August 2011

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • neoadjuvant chemotherapy
  • gemcitabine
  • capecitabine
  • Pancreatic Neoplasms