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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00165854
Other study ID # E7070-E044-209
Secondary ID 2004-002597-33
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated June 26, 2014
Start date March 2003

Study information

Verified date October 2006
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
E7070


Locations

Country Name City State
France Centre Léon Bérard Lyon
France Institut Curie Paris
Germany Universitätsklinikum der GHS-Essen Essen
Netherlands Netherlands Cancer Institute Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
Eisai Limited

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

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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