Biweekly Taxotere in combination with Xeloda as first-line treatment in patients with advanced gastric cancer

Raija Ristamäki0 个研究点目标入组 50 人开始时间: 2005年6月27日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- 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:
•oNeutrophils 1.5 x 109/l
•oPlatelets 100 x 109/l
•oHemoglobin 100 g/l, after transfusion when needed
•- Adequate renal function:
•oserum creatinine 1.25 x upper normal limit)
•- Adequate liver function:
•ototal serum bilirubin 1.25 x upper normal limit
•oALAT 3 x upper normal limit;
•oAFOS 2.5 x upper normal limit (unless bone metastases)
•oin 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

•- 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

发起方

Raija Ristamäki