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

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First Received: November 4, 2008 Last Updated: June 12, 2009 History of Changes

Sponsors and Collaborators:	CONKO-Studiengruppe Sanofi-Aventis medac GmbH Amgen
Information provided by:	CONKO-Studiengruppe
ClinicalTrials.gov Identifier:	NCT00786058

Purpose

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.

Condition	Intervention
Pancreatic Cancer	Drug: OFF in experimental arm

Study Type:	Expanded Access
Official Title:	A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Fluorouracil Gemcitabine

U.S. FDA Resources

Further study details as provided by CONKO-Studiengruppe:

Intervention Details:

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786058

Sponsors and Collaborators

CONKO-Studiengruppe

Sanofi-Aventis

medac GmbH

Amgen

Investigators

Principal Investigator:

Helmut Oettle, PD

CONKO Study Group

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	CONKO Study group ( Helmut Oettle PHD )
Study ID Numbers:	CONKO 003, CCT-NAPN-16751
Study First Received:	November 4, 2008
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00786058 History of Changes
Health Authority:	Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ministry of Health

Keywords provided by CONKO-Studiengruppe:

refractory pancreatic cancer
gemcitabine
phase III
second line

Study placed in the following topic categories:

Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Fluorouracil
Pancreatic Neoplasms
Endocrine System Diseases

Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009