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

NCT00165880 | Terminated Phase 2

• 2 other identifiers: E7070-E044-2132004-000774-31
• Study Type: interventional
• Target: 62
• Locations: 5 countries
• Sites: 33

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

E7070 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• hemoglobin \<10 g/dl;
• neutrophils \<1.5 x 109/L;
• platelets \<100 x 109/L;
• serum bilirubin \>25 µmol/l (1.5 mg/dl);
• other liver parameters \>2.5 x upper normal limit (ULN) (\> 5 x upper normal limit in the presence of hepatic metastases);
• serum creatinine \>1.5 x ULN;
• serum calcium (corrected for albumin) \>=11.5 mg/dl.
• Uncontrolled infections.

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (33)

Charite Universitatsmedizin Berlin

Berlin, D-12200, Germany

Location

Stadt Kliniken Frankfurt-Hochst

Frankfurt, D-65929, Germany

Location

IORC Gmbh

Hamburg, D-22081, Germany

Location

Medizinische Klinik und Poliklinik

Mainz, D-55101, Germany

Location

Zentrum fur Innere Medizin Hamatologie / Onkologie

Stuttgart, D-70376, Germany

Location

Ospedali Ruiniti

Bergamo, I-24128, Italy

Location

Ospedale S. Maria Annunzialata

Florence, I-50011, Italy

Location

Ospedale Morgagni-Pierantoni

Forlì, I-47100, Italy

Location

IST Istituto nazionale per la Ricerca

Genova, I-16132, Italy

Location

Palilinico Universitano

Palermo, I-90127, Italy

Location

Azienda Ospedaliera Pisana

Pisa, I-56126, Italy

Location

A.O. Arciospedate S. Maria Nuova

Reggio Emilia, I-42100, Italy

Location

Ospedale San Filippo Neri

Roma, I-00135, Italy

Location

Arkhangelsk Regional Clinical Oncology Center

Arkhangelsk, 163045, Russia

Location

Chelyabinsk Regional Oncology Center

Chelyabinsk, 454087, Russia

Location

Krasnodar City Oncology Center

Krasnodar, 350040, Russia

Location

Leningrad Regional Oncology Center

Kuzmolovo, 188663, Russia

Location

Hertzen Research Institute of Oncology

Moscow, 125284, Russia

Location

Semashko Central Clinical Hospital

Moscow, 129128, Russia

Location

Rostov Oncology Research Institute

Rostov-on-Don, 344037, Russia

Location

Petrov Research Institute of Oncology

Saint Petersburg, 197758, Russia

Location

Centro Oncologico Regional de Galicia

A Coruña, E-15009, Spain

Location

Hospital Universiatio de Guadalajara

Guadalajara, I-19002, Spain

Location

Hospital Unicersaitario de La Princesa

Madrid, E-28006, Spain

Location

Centro Oncologico Anderson Internacional

Madrid, E-28033, Spain

Location

Hospital Clinico U. Virgen de la Victoria

Málaga, E-29010, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, E-50009, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, I-19002, Spain

Location

Cookridge Hospital

Leeds, LS16 6QB, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, M20 4GJ, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, HA1 2RN, United Kingdom

Location

South West Wales Cancer Institute

Swansea, SA2 8QA, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jantien Wanders

  Eisai Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 14, 2005
• Study Start: December 1, 2004
• Study Completion: September 1, 2007
• Last Updated: July 1, 2014

Record last verified: 2008-03

Locations

IT (8); RU (8); ES (7); DE (5); GB (5)