Clinical trial · Interventional
Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer
Dose Determination of Taxotere®, Eloxatin® and Xeloda® (TEX)in Combination With Herceptin® as First-line Treatment for Patients With HER2 Positive Non-resectable Oesophagus, Cardia or Gastric Cancer (ECV)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Her-TEX
- interventionNames
- Drug: Docetaxel
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- To determine maximum tolerable dose (MTD) for the combination regime TEX
- timeFrame
- 2 years
- description
- The investigators have planned to examine 3 dose levels including 3 patients at each level with escalating doses of docetaxel from 42 mg/m² to 60 mg/m² and fixed doses of oxaliplatin (100 mg/m²), capecitabine 625 mg/m² x 2 and trastuzumab 6 mg/kg.
Secondary outcomes (3)
- measure
- Progression free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available