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

Pancreatic Cancer Clinical Trial

Official title:

A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00786058
• Other study ID #: CONKO 003
• Secondary ID: CCT-NAPN-16751
• Status: Approved for marketing
• Phase: N/A
• First received: November 4, 2008
• Last updated: June 12, 2009

Study information

• Verified date: June 2009
• Source: CONKO-Studiengruppe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Ministry of Health
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
CONKO-Studiengruppe	Amgen, medac GmbH, Sanofi

External Links

•   Link
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