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

Primary Purpose

Pancreatic Cancer

Status

Approved for marketing

Phase

Locations

Study Type

Expanded Access

Intervention

OFF in experimental arm

About this trial

This is an expanded access trial for Pancreatic Cancer focused on measuring refractory pancreatic cancer, gemcitabine, phase III, second line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00786058

First Posted

November 4, 2008

Last Updated

June 12, 2009

Sponsor

CONKO-Studiengruppe

Collaborators

Sanofi, medac GmbH, Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00786058

Brief Title

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

Official Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Approved for marketing

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

CONKO-Studiengruppe

Collaborators

Sanofi, medac GmbH, Amgen

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

refractory pancreatic cancer, gemcitabine, phase III, second line

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

OFF in experimental arm

Other Intervention Name(s)

Eloxatin, Calciumfolinat, 5-Fluorouracil

Intervention 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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helmut Oettle, PD

Organizational Affiliation

CONKO Study Group

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

24982456

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.

Results Reference

derived

Links:

URL

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

Description

Related Info

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

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