NCT00786058 · CITED IN SOURCE DOCUMENTS

A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: Not reported
Status at capture: APPROVED FOR MARKETING
Registry last update: 2009-06-15

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

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.
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

interventions

description
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.
name
OFF in experimental arm
other Names
Eloxatin
Calciumfolinat
5-Fluorouracil
type
DRUG

Study design

Source null

Enrollment

Source null

Registered outcome plans (not posted results)

Full study description

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.

Source references

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.
pmid
24982456
type
DERIVED