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