N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide and E7070 in Colorectal Cancer (CRC) - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Colorectal Cancer (CRC)

Intervention / Treatment

Drug: E7070

Study Type

Interventional

Enrollment

46

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Lyon, France, F-69373
    - Centre Léon Bérard
  - Paris, France, F-75005
    - Institut Curie
Germany
- - Essen, Germany, D-45122
    - Universitätsklinikum der GHS-Essen
Netherlands
- - Amsterdam, Netherlands, 1066 CX
    - Netherlands Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Limited

Investigators

Study Director: Jantien Wanders, Eisai Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria