Colorectal Cancer (CRC) Clinical Trial
Part 1: The primary purpose is to determine the recommended dose of E7070 in combination with capecitabine by dose adjustment. Part 2: The primary purpose is to determine the safety and efficacy of the combination in patients with metastatic CRC resistant to 5-fluorouracil and irinotecan.
Status | Completed |
Enrollment | 46 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Part 1 Inclusion Criteria: - Histologically or cytologically confirmed solid tumour refractory to standard therapy or for whom no established therapy exists - Age >= 18 years - Karnofsky performance status of >= 70% - Life expectancy of >= 3 months - Absolute neutrophil count of >= 1.5 × 109/l, platelet count of ³ 100 × 109/l, haemoglobin level of ³ 10 g/dl (>= 6.2 mmol/l) (prior transfusion is permitted) - Normal hepatic and renal function as defined by serum bilirubin £ 1.5 times the upper limit of normal, ALT and AST £ 2.5 times the upper limit of normal (£ 5 times the upper limit of normal in the presence of hepatic metastases), creatinine clearance ³ 50 ml/min (by Cockroft-Gault formula) - Male and female patients - Written informed consent to participate in the study Part 1 Exclusion Criteria: - More than two previous courses of documented myelosuppresive chemotherapy (epidermal growth factor targeted therapy does not constitute a course of chemotherapy) - 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-FU) - 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 Part 2 Inclusion Criteria: - Ambulant patients with progressive metastatic CRC who have received prior treatment with 5 FU and irinotecan and/or oxaliplatin either as single agents or in combination. Either 5 FU and/or irinotecan and/or oxaliplatin may have been administered in the adjuvant setting or for the treatment of metastatic disease. Patients who have received both 5-FU and irinotecan or oxaliplatin in the adjuvant setting only must have experienced disease recurrence within one year of starting chemotherapy. - At least one unidimensionally measurable lesion according to the RECIST criteria - Age ³ 18 years - Karnofsky performance status of ³ 70% - Life expectancy of ³ 3 months - Absolute neutrophil count of ³ 1.5 × 109/l, platelet count of ³ 100 × 109/l, haemoglobin level of ³ 10 g/dl (³ 6.2 mmol/l) (prior transfusion is permitted) - Normal hepatic and renal function as defined by serum bilirubin £ 1.5 times the upper limit of normal, ALT and AST £ 2.5 times the upper limit of normal (£ 5 times the upper limit of normal in the presence of hepatic metastases), creatinine clearance ³ 50 ml/min (by Cockroft-Gault formula) - Male and female patients - Written informed consent to participate in the study Part 2 Exclusion Criteria: - Prior chemotherapy other than 5-FU, 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 negative 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 start - 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-FU) - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon | |
France | Institut Curie | Paris | |
Germany | Universitätsklinikum der GHS-Essen | Essen | |
Netherlands | Netherlands Cancer Institute | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Eisai Limited |
France, Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the recommended dose of E7070 in combination with capecitabine by dose adjustment; | |||
Primary | to determine the safety, tolerability and efficacy (in terms of response rate and progression-free survival) of the combination in patients with metastatic CRC. | |||
Secondary | Determine the pharmacokinetic profile of capecitabine and E7070 when administered in combination; | |||
Secondary | measure duration of response and stable disease; to measure median and one year survival. |
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