Overview

Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer

Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
All
Summary
The primary aim of this dose-finding study is to determine the maximum tolerated dose of taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third week as first-line treatment in patients with HER2-positive advanced gastro-esophageal cancer. Secondary end points are to evaluate progression-free survival and overall survival.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Odense University Hospital
Collaborators:
Aalborg Universitetshospital
Aalborg University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Treatments:
Capecitabine
Docetaxel
Oxaliplatin
Trastuzumab
Criteria
Inclusion Criteria:

1. Patients with histologically proven ECV-adenocarcinoma, non-resectable or metastatic
disease

2. HER2-positive tumor tissue (IHC 3 + or FISH positive)

3. LVEF > 50 % (MUGA scan or echocardiography)

4. Age ≥ 18 years

5. No prior chemotherapy

6. WHO performance status 0-1

7. Life expectancy of at least 3 months

8. Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L

9. Bilirubin ≤ 1.5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL. In case of
liver metastases no UNL for ASAT and ALAT

10. Creatinine clearance ≥ 50 ml/min. Calculated with the Cockroft-Gault formula

11. No neuropathy

12. Planned treatment start within 8 days after inclusion

Exclusion Criteria:

1. Patients who cannot complete treatment or evaluation

2. Any condition or treatment which after the opinion of the investigator may expose the
patients to a risc or influence the purpose of the study

3. Known hypersensitivity towards any of the study drugs

4. Other malignant disease within the last 5 days, except for non-melanoma skin cancer

5. Other serious disease (e.g. cardiac disease, AMI within 1 year or infection)

6. Pregnant women or nursing women

7. Physical or mental conditions which may prevent absorption of oral treatment