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OpenTrials
Completed

NCT Number: NCT00759226

Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charite Universitätsmedizin Berlin

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine

Drug

Gemcitabine 1000 mg/m2 (30 min)

Other names: Gemzar

Cisplatin

Drug

Cisplatin 30 mg/m2 (90 min)

Other names: Cisplatin medac

5-FU

Drug

5-FU 750 mg/m2 (24h CI)

Other names: 5-FU medac

Folinic acid

Drug

Folinic Acid 200 mg/m2 (30 min)

Other names: Rescuvolin

Primary outcomes

  1. Primary endpoint rate of freedom of progression (PR+CR+SD).

    Time frame: Max. 8 cycles of therapy

Secondary outcomes

  1. Secondary endpoint median survival, progression free survival and toxicity.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

CONKO-Studiengruppe

Other

Collaborators

  • Eli Lilly and Company
  • medac GmbH

Registry information

Official study 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

Acronym: CONKO-101

Important dates

Study start
2002
Primary completion
2005
Study completion
2007
First posted
Sep 25, 2008
Registry last updated
Sep 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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