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Study of E7070 Combined With Capecitabine to Determine Efficacy and Recommended Dose of Combination in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT00165854
First received: September 13, 2005
Last updated: June 26, 2014
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer (CRC)
Drug: E7070
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To determine the recommended dose of E7070 in combination with capecitabine by dose adjustment;
  • 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 Outcome Measures:
  • Determine the pharmacokinetic profile of capecitabine and E7070 when administered in combination;
  • measure duration of response and stable disease; to measure median and one year survival.

Estimated Enrollment: 46
Study Start Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165854

Locations
France
Centre Léon Bérard
Lyon, France, F-69373
Institut Curie
Paris, France, F-75005
Germany
Universitätsklinikum der GHS-Essen
Essen, Germany, D-45122
Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Jantien Wanders Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT00165854     History of Changes
Other Study ID Numbers: E7070-E044-209, 2004-002597-33
Study First Received: September 13, 2005
Last Updated: June 26, 2014
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014