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”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: July 2005

Intervention(s) in this Clinical Trial

• Drug: Gemcitabine
  • Gemcitabine 1000 mg/m2 (30 min)
• Drug: Cisplatin
  • Cisplatin 30 mg/m2 (90 min)
• Drug: 5-FU
  • 5-FU 750 mg/m2 (24h CI)
• Drug: Folinic Acid
  • Folinic Acid 200 mg/m2 (30 min)

Primary Measures

• Primary endpoint rate of freedom of progression (PR+CR+SD).
  • Time Frame: Max. 8 cycles of therapy
    Safety Issue?: No

Secondary Measures

• Secondary endpoint median survival, progression free survival and toxicity.
  • Time Frame: 3 years
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: CONKO-Studiengruppe

Overall Clinical Trial Officials and Contacts

Hanno Riess, MD, PhD Principal Investigator Charite Universitätsmedizin Berlin  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00759226

Study ID Number: CONKO-101

ClinicalTrials.gov Identifier: NCT00759226

Health Authority: Germany: Federal Institute for Drugs and Medical Devices