Docetaxel and Capecitabine in Advanced Gastric Cancer
Stomach Neoplasm, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Stomach Neoplasm focused on measuring gastric cancer, metastatic, locally advanced, docetaxel, capecitabine
Eligibility Criteria
Inclusion Criteria: Patients with histologically proven adenocarcinoma of the stomach or the GE-junction. Patients with distant metastases or patients with locally advanced disease who are not curatively operable proven by laparoscopy or patients with a recurrence after gastrectomy. Patients who did not receive any prior palliative chemotherapy. An adjuvant chemotherapy is allowed. Age between 18 and 75 years. Sufficient bone marrow function defined as leucocytes > 3.0 Gpt/l, thrombocytes > 100 Gpt/l Sufficient liver function defined as bilirubin < 1.5 mg/dl (1.5 x ULN), ALT and AST < 3 x ULN. Sufficient renal function defined as serum creatinine < 1.25 x ULN, or creatinine clearance > 60 ml/min calculated according to Cockroft-Gault Contraception in patients with reproductive potential. Karnofsky-performance-index at least 60% Measurable tumor lesions. Written informed consent of the patient. Exclusion Criteria: Karnofsky-performance-index less or equal 50%. Patients who already received a palliative first-line chemotherapy. Prior second malignancy, except basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix. Parallel radiation therapy Uncontrolled infection. CNS-metastasis Other severe medical disease Prior major surgery for less than 2 weeks Parallel treatment with other experimental therapies. Parallel treatment with any other therapy aiming against the tumor. Chronic diarrhea, subileus. Chronic inflammatory bowel disease or intestinal obstruction. Unable to take oral medication. Pregnancy or breast feeding.
Sites / Locations
- Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology