A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003
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|ClinicalTrials.gov Identifier: NCT00786058|
Expanded Access Status : Approved for marketing
First Posted : November 5, 2008
Last Update Posted : June 15, 2009
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer||Drug: OFF in experimental arm|
Gemcitabine (G) given until progressive disease (PD) is still standard therapy in patients with advanced pancreatic cancer. No standard secondline regimen is available after PD. Best supportive care (BSC) is the main option for these patients. Our phase II study (Pelzer et al, ASCO 2002) showed activity of the OFF (Oxaliplatin/Folinic Acid/5-FU) regimen. To confirm these data we started this multicenter phase III study to examine OFF vs. BSC alone.
165 patients were needed for this study. Following CT/ MRT confirmed PD patients were randomized. Stratification included duration of firstline therapy, Karnofsky Performance Status (KPS) and tumor stage. OFF (outpatient regimen): 5-FU 2g/m² (24h)/FA 200 mg/m² (30min) on d1, d8, d15, d22, additional Oxaliplatin 85mg/m² (2h) on day 8 and 22. Rest on day 23 and 42.
|Study Type :||Expanded Access|
|Official Title:||A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)|
- Drug: OFF in experimental arm
OFF was given according to a six week cycle. FA (500 mg/m2 , 0.5h, i.v.) and 5-FU (2,600 mg/m2, 24-hour, i.v.) were administered on days 1, 8, 15, and 22. Oxaliplatin (85 mg/m2 , 2-4 h, i.v.) was administered directly before FA/ 5-FU on days 8 and 22.Other Names:
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786058
|Principal Investigator:||Helmut Oettle, PD||CONKO Study Group|