An open label dose adjustment and phase II study of E7070 in combination with capecitabine: Part 1: to determine the recommended dose of the combination Part 2: to determine the efficacy of the combination in patients with metastatic colorectal cancer (CRC) who are resistant to or unsuitable for treatment with 5-fluorouracil and irinotecan and/or oxaliplati

• Conditions: Metastatic Colorectal Cancer resistant to or unsuitable for treatment with 5-fluorouracil and irinotecan and/or oxaliplatin

• Registration Number: EUCTR2004-002597-33-DE
• Lead Sponsor: Eisai Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-27
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Ambulant patients with progressive metastatic CRC who have received prior treatment with 5-fluorouracil and irinotecan and/or oxaliplatin; At least one unidimensionally measurable lesion according to the RECIST criteria; Age at least 18 years; Karnofsky performance status of at least 70%; Life expectancy of at least 3 months; Absolute neutrophil count of at least 1.5 × 10(9)/l, platelet count of at least 100 × 10(9)/l, haemoglobin level of at least 10 g/dl (at least 6.2 mmol/l) (prior transfusion is permitted); Normal hepatic and renal function as defined by serum bilirubin less than 1.5 times the upper limit of normal, ALT and AST less than 2.5 times the upper limit of normal (less than 5 times the upper limit of normal in the presence of hepatic metastases), creatinine clearance greater than 50 ml/min (by Cockroft-Gault formula); Male and female patients-; Written informed consent to participate in the study
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

Prior chemotherapy other than 5-fluorouracil and irinotecan and/or oxaliplatin; CNS metastases (a CT or MRI scan should be done if there is a clinical suspicion of CNS metastases); Major surgery, chemotherapy or radiation therapy (except palliative) within 4 weeks of treatment start.
Previous investigational cytotoxic treatment for malignant disease within 30 days before the start of the study; Any treatment with non-oncological investigational drugs within 30 days before the start of the study; Pregnancy or breast feeding (all women of childbearing potential must have a pregnancy test before inclusion in the study; post-menopausal women must be amenorrhoeic for at least 12 months). Female patients must use adequate contraceptive protection; Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection; Uncontrolled infections; Clinically significant cardiac impairment or unstable ischaemic heart disease including a myocardial infarction within three months of study entry; History of alcoholism, drug addiction, or any psychiatric or psychological condition which in the opinion of the investigator would impair study compliance; History of hypersensitivity to sulphonamides; Prior severe or unexpected reaction to fluoropyrimidine therapy (which may be explained by dihydropyrimidine dehydrogenase deficiency or hypersensitivity to 5-fluorouracil; Malabsorption syndrome or other condition which may affect absorption of drug; Concurrent or previous malignancy of a different tumour type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia; Treatment within two weeks before the start of the study with any of the following: coumarin anti-coagulants, terfenadine, cisapride, cyclosporin, tacrolimus, theophylline, diazepam, sulphonylurea hypoglycaemics, phenytoin, or carbamazepine; Legal incapacity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified