An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine

Metastatic Breast Cancer Clinical Trial

Official title:

An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Metastatic Breast Cancer Patients Following Prior Anthracycline and Taxane Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00165880
• Other study ID #: E7070-E044-213
• Secondary ID: 2004-000774-31
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 30, 2014
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: March 2008
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesItaly: Servizio Sanitario Regionale Emilia-Romagna Azienda Unita Sanitaria Locale di Forli (Emilio Romagna Regional Healthcare Service Forli)
• Study type: Interventional

Clinical Trial Summary

The overall purpose of this study is to compare the efficacy, safety and tolerability of indisulam in combination with capecitabine (IC) versus capecitabine (C) monotherapy in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ambulant female patients with metastatic breast cancer who have been treated previously with an anthracycline and a taxane will be enrolled.

• Patients must fulfill the following criteria to be included in the study:

• Histologically or cytologically confirmed breast cancer with at least one --- metastatic uni-dimensionally measurable lesion according to RECIST criteria (the following do not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions).

• Prior treatment with an anthracycline and a taxane.

• All previous treatment (including surgery and radiotherapy) must have been completed at least 4 weeks prior to study entry and any acute toxicities must have resolved.

• Age >= 18 years.

• Karnofsky performance status of >= 70%.

• Written informed consent to participate in the study.

Exclusion Criteria:

Patients with the following characteristics will not be included in the study:

• Previously received greater than two prior chemotherapy regimens for metastatic breast cancer.

• Previously received greater than three prior chemotherapy regimens in total (including neo-adjuvant and adjuvant regimens) for breast cancer.

• Primary diagnosis of inflammatory breast cancer, confirmed by histology or cytology.

• Untreated brain metastases (patients who have been treated for CNS metastases must be asymptomatic and radiologically stable for 3 months prior to entry). Patients must not have clinical symptoms from brain metastases and must not be taking corticosteroids for the treatment of brain metastases. Patients must not have leptomeningeal metastases.

• Concurrent or previous malignancy of a different tumor type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia.

• Any of the following laboratory parameters:

1. hemoglobin <10 g/dl;

2. neutrophils <1.5 x 109/L;

3. platelets <100 x 109/L;

4. serum bilirubin >25 µmol/l (1.5 mg/dl);

5. other liver parameters >2.5 x upper normal limit (ULN) (> 5 x upper normal limit in the presence of hepatic metastases);

6. serum creatinine >1.5 x ULN;

7. serum calcium (corrected for albumin) >=11.5 mg/dl.

• Uncontrolled infections.

• Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start.

• Malabsorption syndrome or other condition which may affect drug absorption.

• History of hypersensitivity to sulfonamides.

• Prior severe or unexpected reaction to fluoropyrimidine therapy (which may be explained by dihydropyrimidine dehydrogenase deficiency or hypersensitivity to 5-fluorouracil).

• Any treatment with investigational drugs within 30 days before the start of the study.

• Pregnancy or lactation (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Fertile patients must use adequate contraceptive protection.

• History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Metastatic Breast Cancer

Intervention

Drug:
• E7070

Locations

Country	Name	City	State
Germany	Charite Universitatsmedizin Berlin	Berlin
Germany	Stadt Kliniken Frankfurt-Hochst	Frankfurt
Germany	IORC Gmbh	Hamburg
Germany	Medizinische Klinik und Poliklinik	Mainz
Germany	Zentrum fur Innere Medizin Hamatologie / Onkologie	Stuttgart
Italy	Ospedali Ruiniti	Bergamo
Italy	Ospedale S. Maria Annunzialata	Firenze
Italy	Ospedale Morgagni-Pierantoni	Forli
Italy	IST Istituto nazionale per la Ricerca	Genova
Italy	Palilinico Universitano	Palermo
Italy	Azienda Ospedaliera Pisana	Pisa
Italy	A.O. Arciospedate S. Maria Nuova	Reggio Emilia
Italy	Ospedale San Filippo Neri	Roma
Russian Federation	Arkhangelsk Regional Clinical Oncology Center	Arkhangelsk
Russian Federation	Chelyabinsk Regional Oncology Center	Chelyabinsk
Russian Federation	Krasnodar City Oncology Center	Krasnodar
Russian Federation	Leningrad Regional Oncology Center	Kuzmolovo
Russian Federation	Hertzen Research Institute of Oncology	Moscow
Russian Federation	Semashko Central Clinical Hospital	Moscow
Russian Federation	Rostov Oncology Research Institute	Rostov-on-Don
Russian Federation	Petrov Research Institute of Oncology	St. Petersburg
Spain	Hospital Universiatio de Guadalajara	Guadalajara
Spain	Centro Oncologico Regional de Galicia	La Coruna
Spain	Centro Oncologico Anderson Internacional	Madrid
Spain	Hospital Unicersaitario de La Princesa	Madrid
Spain	Hospital Clinico U. Virgen de la Victoria	Malaga
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
United Kingdom	Cookridge Hospital	Leeds
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	Christie Hospital NHS Trust	Manchester
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	South West Wales Cancer Institute	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Countries where clinical trial is conducted

Germany,  Italy,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor measurements to be done by CT/MRI or photography in accordance with the RECIST criteria and radiography protocol provided. Six month and median overall survival, pain and analgesia score.
Secondary	Clinical examination, adverse events, laboratory screens and electrocardiograms. Also, independent radiological review using RECIST criteria.