Overview

Randomized Phase II Study of FOLFOX Versus FOLFIRI.3 in Gemcitabine-refractory Pancreatic Cancer

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators are to evaluate the efficacy and safety of FOLFOX or FOLFIRI.3 combination chemotherapy as second-line salvage chemotherapy in patients with advanced pancreatic carcinoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Treatments:
Gemcitabine
Irinotecan
Criteria
Inclusion Criteria:

1. Pathologically proven pancreatic adenocarcinoma

2. Age 18 year or older

3. ECOG performance status of 2 or lower

4. Documented disease progression while receiving or within 6 months after discontinuing
gemcitabine-based first-line or adjuvant chemotherapy

5. Adequate bone marrow function A. WBCs > 4,000/µL, absolute neutrophil count
[ANC]>1,500/µL B. Hemoglobin >9.0 g/dL C. Platelets > 100,000/µL

6. Adequate kidney function (creatinine<1.5 mg/dL)

7. Adequate liver function (bilirubin<1.5 mg/dL [< 2.5 mg/dL for obstructive jaundice
with adequately decompressed bile duct obstruction], transaminases levels<3 times the
upper normal limit, and serum albumin of >2.5 mg/dL)

8. No serious other medical condition that would preclude treatment

Exclusion Criteria:

1. Other tumor type than adenocarcinoma

2. Evidence of GI bleeding or GI obstruction

3. Presence or history of CNS metastasis

4. Axial skeletal radiotherapy within 6 months

5. Neuropathy grade 2 or worse