Clinical trial NCT00165880: An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
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 outcomes:
measure: Clinical examination, adverse events, laboratory screens and electrocardiograms. Also, independent radiological review using RECIST criteria.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Frankfurt
country: Germany
facility: Stadt Kliniken Frankfurt-Hochst
city: Hamburg
country: Germany
facility: IORC Gmbh
city: Mainz
country: Germany
facility: Medizinische Klinik und Poliklinik
city: Stuttgart
country: Germany
facility: Zentrum fur Innere Medizin Hamatologie / Onkologie
city: Bergamo
country: Italy
facility: Ospedali Ruiniti
city: Firenze
country: Italy
facility: Ospedale S. Maria Annunzialata
city: Forli
country: Italy
facility: Ospedale Morgagni-Pierantoni
city: Genova
country: Italy
facility: IST Istituto nazionale per la Ricerca
city: Palermo
country: Italy
facility: Palilinico Universitano
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana
city: Reggio Emilia
country: Italy
facility: A.O. Arciospedate S. Maria Nuova
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Center
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Oncology Center
city: Krasnodar
country: Russian Federation
facility: Krasnodar City Oncology Center
city: Kuzmolovo
country: Russian Federation
facility: Leningrad Regional Oncology Center
city: Moscow
country: Russian Federation
facility: Hertzen Research Institute of Oncology
city: Moscow
country: Russian Federation
facility: Semashko Central Clinical Hospital
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Oncology Research Institute
city: St. Petersburg
country: Russian Federation
facility: Petrov Research Institute of Oncology
city: Guadalajara
country: Spain
facility: Hospital Universiatio de Guadalajara
city: La Coruna
country: Spain
facility: Centro Oncologico Regional de Galicia
city: Madrid
country: Spain
facility: Hospital Unicersaitario de La Princesa
city: Madrid
country: Spain
facility: Centro Oncologico Anderson Internacional
city: Malaga
country: Spain
facility: Hospital Clinico U. Virgen de la Victoria
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Leeds
country: United Kingdom
facility: Cookridge Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Swansea
country: United Kingdom
facility: South West Wales Cancer Institute
Study officials:
affiliation: Eisai Limited
name: Jantien Wanders
role: STUDY_DIRECTOR
References: