Overview

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