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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
medac GmbH
Information provided by:
CONKO-Studiengruppe
ClinicalTrials.gov Identifier:
NCT00759226
First received: September 24, 2008
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00759226

Locations
Germany
Charite Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
CONKO-Studiengruppe
Eli Lilly and Company
medac GmbH
Investigators
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
ClinicalTrials.gov 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
Gemcitabine
Cisplatin
5-FU
Folinic Acid
inoperable esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gemcitabine
Cisplatin
Fluorouracil
Leucovorin
Folic Acid
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on April 16, 2014