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

Esophageal Cancer Clinical Trial

— CONKO-101  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759226
• Other study ID #: CONKO-101
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2008
• Last updated: September 25, 2008
• Start date: July 2002
• Est. completion date: August 2007

Study information

• Verified date: September 2008
• Source: CONKO-Studiengruppe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Charite Universitätsmedizin Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
CONKO-Studiengruppe	Eli Lilly and Company, medac GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint rate of freedom of progression (PR+CR+SD).		Max. 8 cycles of therapy	No
Secondary	Secondary endpoint median survival, progression free survival and toxicity.		3 years	Yes