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

NCT ID: NCT00786058

Last Updated: 2009-06-15

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Pancreatic Cancer

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Eloxatin; Calciumfolinat; 5-Fluorouracil

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.

• 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 Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

medac GmbH

INDUSTRY

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: collaborator

CONKO-Studiengruppe

OTHER

Sponsor Role: lead

Responsible Party

CONKO Study group

Principal Investigators

Helmut Oettle, PD

Role: PRINCIPAL_INVESTIGATOR

CONKO Study Group

References

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.

Reference Type: DERIVED

PMID: 24982456 (View on PubMed)

Related Links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda

Related Info

Other Identifiers

CCT-NAPN-16751

Identifier Type: -

Identifier Source: secondary_id

CONKO 003

Identifier Type: -

Identifier Source: org_study_id