Advanced adenocarcinoma of the stomach or the gastro-esophageal junction
Conditions
Interventions
Treatment consists of:
- Docetaxel as a 1-hour i.v. infusion in a 250 ml 0.9% NaCl solution on day 1,
followed by
- Oxaliplatin as a 2-hour i.v. infusion in a 500 ml 5% glucose solution on day
1,
-
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced, histologically confirmed, adenocarcinoma of the stomach or the gastroesophageal junction 2. Previous (neo)adjuvant chemotherapy with epirubicin, cisplatin, 5-FU or capecitabine is allowed provided that a relapse occurred > 12 months after chemotherapy. Otherwise patients should be chemonaive. 3. Measurable or evaluable non-measurable disease 4. Age 18 years or older 5. Able to swallow and retain oral medication 6. Able and willing to undergo blood sampling for pharmacogenetic and pharmacokinetic analysis, and circulating tumor cells analysis 7. Life expectancy of at least 3 months allowing adequate follow up of toxicity evalution and antitumor activity 8. Minimal acceptable safety laboratory values a. ANC of 1.5 x 109 /L or higher b. Platelet count of 100 x 109 /L or higher c. Haemoglobin level of 6.0 mmol/l or higher - transfusion is permitted d. Hepatic function as defined by serum bilirubin of less 1.5 x ULN or less, ALT and AST and alkaline phosphatase 2.5 x ULN or less e. Renal function as defined by serum creatinine 1.5 x ULN or less or creatinine clearance more than 50 ml/min (by Cockcroft-Gault formula). 9. Able and willing to give written informed consent 10. WHO performance status of 0, 1 or 2
Exclusion criteria
Exclusion criteria: 1. Known CNS or leptomeningeal metastases (a CT or MRI scan should be done if there is a clinical suspicion of CNS metastases) 2. History of another primary cancer, except curatively treated in situ cervical cancer or resected non-melanoma skin cancer 3. Uncontrolled infectious disease or known HIV, hepatitis B or hepatitis C patients 4. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up 5. Women who are pregnant or breast feeding 6. Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study 7. Any other medical condition that would interfere with study procedures and/or decrease safety of the protocol treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of MTD and DLT of DOCCS in patients with advanced cancer of stomach or gastro-esophageal junction. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Determination of preliminary clinical activity of DOCCS - Pharmacokinetic parameters for determination of the pharmacokinetic of DOCCs - Determination of circulating tumor cells before start of treatment and after cycle 1, and to correlate changes with clinical outcome - Determination of platinum DNA adducts in gastric- and tumortissue, 24 h after start oxaliplatin (optional) | — |
Countries
Netherlands
Outcome results
None listed