advanced gastric cancer
Conditions
Interventions
Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Xeloda
Product Name: Xeloda
Pharmaceutical Form: Tablet
Sponsors
Raija Ristamäki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed advanced, inoperable gastric adenocarcinoma - over18 years of age - WHO performance status at least 2 - Cancer stage IV - Measurable (according to RECIST criteria) or evaluable lesion - No previous chemotherapy, except adjuvant chemotherapy over 6 months ago - Adequate hematological function: o Neutrophils 1.5 x 109/l o Platelets 100 x 109/l o Hemoglobin 100 g/l, after transfusion when needed - Adequate renal function: o serum creatinine 1.25 x upper normal limit) - Adequate liver function: o total serum bilirubin 1.25 x upper normal limit o ALAT 3 x upper normal limit; o AFOS 2.5 x upper normal limit (unless bone metastases) o in case of liver metastasis: total serum bilirubin 1.5 x upper normal limit, ALAT 5 x upper normal limit - Consent form signed and dated before 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
Exclusion criteria
Exclusion criteria: - Unresolved bowel obstruction or sub obstruction - History of inflammatory bowel disease or chronic diarrhea - Clinically significant malabsorption syndrome - Inability to swallow tablets - Presence of CNS metastases - Known dihydropyrimidine dehydrogenase (DPD) deficiency - Peripheral neuropathy * grade 2, unless related to mechanical etiology - Lack of physical integrity of the upper gastrointestinal tract - History of allergy to drugs containing the excipient TWEEN 80® and/ or 5-fluorouracil - History of prior serious allergic reactions such as anaphylactic shock - Pregnant or lactating women (or potentially fertile women not using adequate contraception) - Concurrent severe and/or uncontrolled co-morbid medical condition such as uncontrolled infection, hypertension, ischemic heart disease, myocardial infarction within previous 6 months, congestive heart failure - Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery - Concomitant administration of any other experimental drug under investigation: concurrent treatment with any other anti-cancer therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the changes in Quality of Life (measured by EORTC QLQ-30) during the treatment period. The overall aim during the treatment period is to evaluate whether quality of life remains stable or improves from baseline The specific aims for QOL study are: 1.To describe the effects on QOL findings in patients with advanced gastric cancer receiving Taxotere and Xeloda. 2.To explore the changes in QOL from baseline to end of treatment. 3.To study whether baseline QOL and/or changes in QOL scores from baseline are prognostic for compliance for treatment. 4.To study weather baseline QOL or changes in QOL scores from baseline are prognostic for TTP or OS ;Secondary Objective: The secondary objectives of the study are the overall response rate (ORR) as defined by RECIST criteria, overall survival (OS) and to evaluate the toxicity profile of the combination treatment in this patient group according to NCI-CTC criteria. ;Primary end point(s): To define whether there are changes in quality of life during the chosen chemotherapy regimen. | — |
Countries
Finland
Outcome results
None listed