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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165880
Recruitment Status : Terminated (This study was stopped prematurely due to lack of efficacy.)
First Posted : September 14, 2005
Last Update Posted : July 1, 2014
Information provided by:
Eisai Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: E7070 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : December 2004
Actual Study Completion Date : September 2007

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Primary Outcome Measures :
  1. 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 :
  1. Clinical examination, adverse events, laboratory screens and electrocardiograms. Also, independent radiological review using RECIST criteria.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165880

Charite Universitatsmedizin Berlin
Berlin, Germany, D-12200
Stadt Kliniken Frankfurt-Hochst
Frankfurt, Germany, D-65929
Hamburg, Germany, D-22081
Medizinische Klinik und Poliklinik
Mainz, Germany, D-55101
Zentrum fur Innere Medizin Hamatologie / Onkologie
Stuttgart, Germany, D-70376
Ospedali Ruiniti
Bergamo, Italy, I-24128
Ospedale S. Maria Annunzialata
Firenze, Italy, I-50011
Ospedale Morgagni-Pierantoni
Forli, Italy, I-47100
IST Istituto nazionale per la Ricerca
Genova, Italy, I-16132
Palilinico Universitano
Palermo, Italy, I-90127
Azienda Ospedaliera Pisana
Pisa, Italy, I-56126
A.O. Arciospedate S. Maria Nuova
Reggio Emilia, Italy, I-42100
Ospedale San Filippo Neri
Roma, Italy, I-00135
Russian Federation
Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk, Russian Federation, 163045
Chelyabinsk Regional Oncology Center
Chelyabinsk, Russian Federation, 454087
Krasnodar City Oncology Center
Krasnodar, Russian Federation, 350040
Leningrad Regional Oncology Center
Kuzmolovo, Russian Federation, 188663
Hertzen Research Institute of Oncology
Moscow, Russian Federation, 125284
Semashko Central Clinical Hospital
Moscow, Russian Federation, 129128
Rostov Oncology Research Institute
Rostov-on-Don, Russian Federation, 344037
Petrov Research Institute of Oncology
St. Petersburg, Russian Federation, 197758
Hospital Universiatio de Guadalajara
Guadalajara, Spain, I-19002
Centro Oncologico Regional de Galicia
La Coruna, Spain, E-15009
Hospital Unicersaitario de La Princesa
Madrid, Spain, E-28006
Centro Oncologico Anderson Internacional
Madrid, Spain, E-28033
Hospital Clinico U. Virgen de la Victoria
Malaga, Spain, E-29010
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, E-50009
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, I-19002
United Kingdom
Cookridge Hospital
Leeds, United Kingdom, LS16 6QB
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4GJ
Mount Vernon Cancer Centre
Northwood, United Kingdom, HA1 2RN
South West Wales Cancer Institute
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Eisai Limited
Study Director: Jantien Wanders Eisai Limited Identifier: NCT00165880     History of Changes
Other Study ID Numbers: E7070-E044-213
2004-000774-31 ( EudraCT Number )
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: March 2008

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents