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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CONKO-Studiengruppe
• Collaborators: Eli Lilly and Company; medac GmbH
• Treatments: Cisplatin; Fluorouracil; Folic Acid; Gemcitabine; Leucovorin; Levoleucovorin

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