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

This study has been completed.
Eli Lilly and Company
medac GmbH
Information provided by:
CONKO-Studiengruppe Identifier:
First received: September 24, 2008
Last updated: September 25, 2008
Last verified: September 2008

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 Intervention Phase
Esophageal Cancer
Drug: Gemcitabine
Drug: Cisplatin
Drug: 5-FU
Drug: Folinic Acid
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by CONKO-Studiengruppe:

Primary Outcome Measures:
  • Primary endpoint rate of freedom of progression (PR+CR+SD). [ Time Frame: Max. 8 cycles of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoint median survival, progression free survival and toxicity. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: July 2002
Study Completion Date: August 2007
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Prof. Hanno Riess, Dr. Helmut Oettle, Charite Universitätsmedizin Berlin Identifier: NCT00759226     History of Changes
Other Study ID Numbers: CONKO-101
Study First Received: September 24, 2008
Last Updated: September 25, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Vitamin B Complex
Growth Substances
Antidotes processed this record on April 15, 2014