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

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Sponsor:
Collaborators:
Sanofi
medac GmbH
Amgen
Information provided by:
CONKO-Studiengruppe
ClinicalTrials.gov Identifier:
NCT00786058
First received: November 4, 2008
Last updated: June 12, 2009
Last verified: June 2009
  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     What is 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:


Further study details as provided by CONKO-Studiengruppe:

Intervention Details:
    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.
    Other Names:
    • Eloxatin
    • Calciumfolinat
    • 5-Fluorouracil
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
CONKO-Studiengruppe
Sanofi
medac GmbH
Amgen
Investigators
Principal Investigator: Helmut Oettle, PD CONKO Study Group
  More Information

Additional Information:
No publications provided

Responsible Party: Helmut Oettle PHD, CONKO Study group
ClinicalTrials.gov Identifier: NCT00786058     History of Changes
Other Study ID Numbers: CONKO 003, CCT-NAPN-16751
Study First Received: November 4, 2008
Last Updated: June 12, 2009
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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014