Status:
APPROVED_FOR_MARKETING
A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003
Lead Sponsor:
CONKO-Studiengruppe
Collaborating Sponsors:
Sanofi
medac GmbH
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/ 5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma that had progressed during first line gemcitabine therapy were eligible for inclusion in the study.
- Other inclusion criteria were:
- Age \> 18 years
- Karnofsky performance status \> 70%
- Bidimensionally measurable reference lesion, adequate laboratory values for hematology (white blood cell \[WBC\] count \> 3.5´109/L, platelet count \> 100´109/L), renal function (creatine clearance \> 30 ml/min) and hepatic function (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \< 2.5 ´ upper normal limit \[UNL\] and in the case of liver metastasis \< 5 x UNL)
- As well as controlled pain
Exclusion
- Patients were excluded from the study if they had any severe concurrent medical condition interfering with planned therapy, serious cardiac disease, sensory/ motor neuropathy \> grade 2 or had previous or current malignancies at other origin; besides, pregnant or lactating women were excluded.
- All patients provided written informed consent.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00786058
Last Update
June 15 2009
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