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

June 30, 2014 updated by: Eisai Limited

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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

  • Germany
      • Berlin, Germany, D-12200
        • Charite Universitatsmedizin Berlin
      • Frankfurt, Germany, D-65929
        • Stadt Kliniken Frankfurt-Hochst
      • Hamburg, Germany, D-22081
        • IORC GmbH
      • Mainz, Germany, D-55101
        • Medizinische Klinik und Poliklinik
      • Stuttgart, Germany, D-70376
        • Zentrum fur Innere Medizin Hamatologie / Onkologie
  • Italy
      • Bergamo, Italy, I-24128
        • Ospedali Ruiniti
      • Firenze, Italy, I-50011
        • Ospedale S. Maria Annunzialata
      • Forli, Italy, I-47100
        • Ospedale Morgagni-Pierantoni
      • Genova, Italy, I-16132
        • IST Istituto nazionale per la Ricerca
      • Palermo, Italy, I-90127
        • Palilinico Universitano
      • Pisa, Italy, I-56126
        • Azienda Ospedaliera Pisana
      • Reggio Emilia, Italy, I-42100
        • A.O. Arciospedate S. Maria Nuova
      • Roma, Italy, I-00135
        • Ospedale San Filippo Neri
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Arkhangelsk Regional Clinical Oncology Center
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Oncology Center
      • Krasnodar, Russian Federation, 350040
        • Krasnodar City Oncology Center
      • Kuzmolovo, Russian Federation, 188663
        • Leningrad Regional Oncology Center
      • Moscow, Russian Federation, 125284
        • Hertzen Research Institute of Oncology
      • Moscow, Russian Federation, 129128
        • Semashko Central Clinical Hospital
      • Rostov-on-Don, Russian Federation, 344037
        • Rostov Oncology Research Institute
      • St. Petersburg, Russian Federation, 197758
        • Petrov Research Institute of Oncology
  • Spain
      • Guadalajara, Spain, I-19002
        • Hospital Universiatio de Guadalajara
      • La Coruna, Spain, E-15009
        • Centro Oncologico Regional de Galicia
      • Madrid, Spain, E-28006
        • Hospital Unicersaitario de La Princesa
      • Madrid, Spain, E-28033
        • Centro Oncologico Anderson Internacional
      • Malaga, Spain, E-29010
        • Hospital Clinico U. Virgen de la Victoria
      • Zaragoza, Spain, E-50009
        • Hospital Clínico Universitario Lozano Blesa
      • Zaragoza, Spain, I-19002
        • Hospital Clínico Universitario Lozano Blesa
  • United Kingdom
      • Leeds, United Kingdom, LS16 6QB
        • Cookridge Hospital
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • Manchester, United Kingdom, M20 4GJ
        • Christie Hospital NHS Trust
      • Northwood, United Kingdom, HA1 2RN
        • Mount Vernon Cancer Centre
      • Swansea, United Kingdom, SA2 8QA
        • South West Wales 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

Female

Description

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 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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
Clinical examination, adverse events, laboratory screens and electrocardiograms. Also, independent radiological review using RECIST criteria.

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

December 1, 2004

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7070-E044-213
  • 2004-000774-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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