Clinical trial NCT00786058: A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003
Official title: A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Pancreatic Cancer
Keywords: refractory pancreatic cancer
gemcitabine
phase III
second line
Lead sponsor: CONKO-Studiengruppe
Sponsor class: OTHER
Collaborators: name: Sanofi
name: medac GmbH
name: Amgen
First posted: 2008-11-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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 (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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CONKO Study Group
name: Helmut Oettle, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Gorner M, Molle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dorken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014 Aug 10;32(23):2423-9. doi: 10.1200/JCO.2013.53.6995. Epub 2014 Jun 30.