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

Sponsor
Eisai Limited (Industry)
Overall Status
Terminated
CT.gov ID
NCT00165880
Collaborator
(none)
62
Enrollment
33
Locations
33
Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Dec 1, 2004
Actual Study Completion Date :
Sep 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Eisai Limited

Investigators

  • Study Director: Jantien Wanders, Eisai Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00165880
Other Study ID Numbers:
  • E7070-E044-213
  • 2004-000774-31
First Posted:
Sep 14, 2005
Last Update Posted:
Jul 1, 2014
Last Verified:
Mar 1, 2008
Additional relevant MeSH terms:
Breast Neoplasms
N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide

Study Results

No Results Posted as of Jul 1, 2014