Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer (CONKO-101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00759226
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : September 26, 2008
Eli Lilly and Company
medac GmbH
Information provided by:

Brief Summary:
This multicenter open labeled phase 2 trial examines the efficacy of a combination of Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min) and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal cancer. The combination was considered to be suitable for further evaluation with a freedom of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable patients were needed based on a 2-Stage Simon design with a first evaluation after 25 evaluable patients.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Gemcitabine Drug: Cisplatin Drug: 5-FU Drug: Folinic Acid Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Labeled Phase 2 Study of Gemcitabine in Combination With Cisplatin, 5-FU (24h CI) and Folinic Acid in Patients With Inoperable Esophageal Cancer
Study Start Date : July 2002
Actual Primary Completion Date : July 2005
Actual Study Completion Date : August 2007

Intervention Details:
    Drug: Gemcitabine
    Gemcitabine 1000 mg/m2 (30 min)
    Other Name: Gemzar
    Drug: Cisplatin
    Cisplatin 30 mg/m2 (90 min)
    Other Name: Cisplatin medac
    Drug: 5-FU
    5-FU 750 mg/m2 (24h CI)
    Other Name: 5-FU medac
    Drug: Folinic Acid
    Folinic Acid 200 mg/m2 (30 min)
    Other Name: Rescuvolin

Primary Outcome Measures :
  1. Primary endpoint rate of freedom of progression (PR+CR+SD). [ Time Frame: Max. 8 cycles of therapy ]

Secondary Outcome Measures :
  1. Secondary endpoint median survival, progression free survival and toxicity. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age>=18
  • Histologically proven inoperable esophageal cancer
  • Karnofsky Performance status >=60%
  • Estimated life expectancy of > 12 weeks
  • Measurable disease
  • No other oncologic therapy
  • Measurable disease
  • Adequate bone marrow function
  • Geographic proximity and compliance
  • Informed consent
  • Negative pregnancy test and adequate contraception

Exclusion Criteria:

  • Insufficient hepatic or renal function
  • Elevated serum calcium
  • Pregnancy/breast feeding
  • Active infection
  • Other malignancies
  • Systemic tumour complications requiring emergency interventions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00759226

Charite Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Eli Lilly and Company
medac GmbH
Principal Investigator: Hanno Riess, MD, PhD Charite Universitätsmedizin Berlin

Responsible Party: Prof. Hanno Riess, Dr. Helmut Oettle, Charite Universitätsmedizin Berlin Identifier: NCT00759226     History of Changes
Other Study ID Numbers: CONKO-101
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

Keywords provided by CONKO-Studiengruppe:
esophageal cancer
Folinic Acid
inoperable esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Folic Acid
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex