Dose determination of Taxotere®, Eloxatin® and Xeloda® (TEX) in combination with Herpectin® as first line treatment to patients with HER2-positive non-resectable esophagus, cardia or gastric cancer - Her-Tex
- Conditions
- Esophagus, cardiac or ventricular cancerMedDRA version: 14.0Level: LLTClassification code 10025899Term: Malignant neoplasm of esophagusSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-021016-41-DK
- Lead Sponsor
- Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
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 eccocardiography)
4. Age = 18 years
5. No prior chemotherapy
6. WHO performance status 0-1
7. Lifeexpectancy 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 formular
11. No neuropathy
12. Planned treatment start within 8 days after inclusion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To determine maximum tolerable dose (MTD) for the combination regime TEX (docetaxel, oxaliplatin and capecitabine) + trastuzumab and to evaluate the toxicity<br>;Secondary Objective: - Progression free survival<br>- Survival<br>- Response rate;Primary end point(s): The primary end point is to determine maximum tolerable dose (MTD) of the combination of TEX + trastuzumab. Further the toxicity will be evaluated.
- Secondary Outcome Measures
Name Time Method