Status:
COMPLETED
Randomized Phase II Study of FOLFOX Versus FOLFIRI.3 in Gemcitabine-refractory Pancreatic Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Given the poor response rate, usually less than 20% in gemcitabine-based doublet in the first-line setting for advanced pancreatic cancer, an additional problem in the therapeutic management of this c...
Eligibility Criteria
Inclusion
- Pathologically proven pancreatic adenocarcinoma
- Age 18 year or older
- ECOG performance status of 2 or lower
- Documented disease progression while receiving or within 6 months after discontinuing gemcitabine-based first-line or adjuvant chemotherapy
- 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
- Adequate kidney function (creatinine\<1.5 mg/dL)
- 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)
- No serious other medical condition that would preclude treatment
Exclusion
- Other tumor type than adenocarcinoma
- Evidence of GI bleeding or GI obstruction
- Presence or history of CNS metastasis
- Axial skeletal radiotherapy within 6 months
- Neuropathy grade 2 or worse
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00786006
Start Date
March 1 2007
End Date
September 1 2009
Last Update
December 6 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea