Locally advanced or metastatic adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction or stomach. MedDRA version: 8.1 Level: LLT Classification code 10055102 Term: Oesophageal cancer metastatic
Conditions
Interventions
Trade Name: Taxotere
Product Name: Docetaxel
Product Code: Not applicable
Pharmaceutical Form: Intravenous infusion
CAS Number: 114977-
Sponsors
North Wales NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in the trial 2. Male or female 18 years or older 3. Histologically verified locally advanced (deemed unsuitable for radical treatment) or metastatic adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction or stomach. Locally recurrent or metastatic disease following radical treatment is permitted. 4. Uni-dimensional measurable disease on MRI/CT in accordance with RECIST guidelines 5. No prior chemotherapy 6. Creatinine clearance of greater than or equal to 60 mls/minute. 7. Adequate hepatic function: Total bilirubin 3 x 10^9/l, neutrophils > 1.5 x 10^9/l, platelets > 100 x 10^9/l 9. Previous radiotherapy is permitted where relapse is outside the radiotherapy fields 10. Patients should have a projected life expectancy of at least 3 months 11. WHO PS 0, 1 or 2 12. Patients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervix 13. Previous chemotherapy with platins, taxanes or fluoropyrimidines is not permitted. 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
Exclusion criteria
Exclusion criteria: 1. Any patient with a medical or psychiatric condition that impairs their ability to give informed consent 2. Any serious uncontrolled medical conditions 3. Any pregnant or lactating woman. Any woman of childbearing potential must have a pregnancy test prior to randomisation and must take adequate precautions to prevent pregnancy during treatment. Any man with a partner of child bearing potential must take adequate precautions to prevent pregnancy during treatment. 4. Any patient unable to complete the quality of life questionnaire 5. Subjects considered by the investigator to be at risk of transmitting any infection through blood or other body fluid including Aquired Immune Deficiency Syndrome (AIDS), or other sexually transmitted disease or hepatitis. 6. Patient participation in other studies 7. Planned radiotherapy in the area of disease which is being assessed for response.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The phase I objective is to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of a chemotherapy regime called 'TCX' (Taxotere,TM, cisplatinum and Xeloda,TM) when it is given every 3 weeks in patients with advanced oesophagogastric cancer. The phase II objective is to determine the efficacy of the regime based on response rate using RECIST criteria and to confirm a recommended dose. ; Secondary Objective: To determine time to disease progression. To determine time to treatment failure. To determine duration of response. To determine overall survival of patients. To assess impact on quality of life. To continue to evaluate toxicity and the safety of the regime during the phase II element of the study. To determine the resection rate and pathological response in locally advanced disease. ; Primary end point(s): For the Phase I part of the study, the primary outcome measure will be the determination of the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) for a three-weekly regime of 'TCX' (Taxotere, cisplatinum and Xeloda). For the Phase II part the primary outcome measure will be evidence of efficacy based on response rate using RECIST criteria as well as confirmation of the recommended dose. | — |
Countries
United Kingdom
Outcome results
None listed