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

NCT00759226 | Completed Phase 2 DMC

• 1 other identifier: CONKO-101
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Keywords

esophageal cancer; Gemcitabine; Cisplatin; 5-FU; Folinic Acid; inoperable esophageal cancer

Outcome Measures

Primary Outcomes (1)

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

  Max. 8 cycles of therapy

Secondary Outcomes (1)

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

  3 years

Interventions

Gemcitabine DRUG

Gemcitabine 1000 mg/m2 (30 min)

Also known as: Gemzar

Cisplatin DRUG

Cisplatin 30 mg/m2 (90 min)

Also known as: Cisplatin medac

5-FU DRUG

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

Also known as: 5-FU medac

Folinic Acid DRUG

Folinic Acid 200 mg/m2 (30 min)

Also known as: Rescuvolin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Insufficient hepatic or renal function
• Elevated serum calcium
• Pregnancy/breast feeding
• Active infection
• Other malignancies
• Systemic tumour complications requiring emergency interventions

Sponsors & Collaborators

• CONKO-Studiengruppe: lead
• Eli Lilly and Company: collaborator
• medac GmbH: collaborator

Study Sites (1)

Charite Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Gemcitabine; Cisplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Hanno Riess, MD, PhD

  Charite Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: July 1, 2002
• Primary Completion: July 1, 2005
• Study Completion: August 1, 2007
• Last Updated: September 26, 2008

Record last verified: 2008-09

Locations

DE (1)