EPO906 Therapy in Patients With Advanced Breast Cancer - Full Text View

Purpose

This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause breast cancer.

Condition	Intervention	Phase
Breast Neoplasms	Drug: epothilone b	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Epothilone B Ixabepilone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast Cancer

Further study details as provided by Novartis:

Primary Outcome Measures:

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures:

Time to progression
Overall survival

Estimated Enrollment:

48

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

The following patients may be eligible for this study:

Histologically or cytologically documented evidence of disease with at least one measurable lesion;
Life expectancy of greater than three (3) months;
Patients who have had only one prior therapy for metastatic disease;
Patients who have received prior treatment with hormonal agents or who have had prior treatment regimens of radiotherapy in addition to one or no previous chemotherapy regimens are eligible;
Patients who have had no prior therapy for metastatic disease, but who have received a taxane and an anthracycline (single or combination therapy) as adjuvant treatment, are eligible. For patients who have had previous radiation therapy to the target lesion(s), the lesion(s) must since have demonstrated progression.

Exclusion Criteria

The following patients are not eligible for this study:

Bone-only disease;
Symptomatic pleural effusions;
Symptomatic CNS metastases or leptomeningeal involvement;
Any peripheral neuropathy or unresolved diarrhea greater than Grade 1;
Severe cardiac insufficiency;
Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports;
History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma ckin cancer or cervical cancer in situ;
Active or suspected acute or chronic uncontrolled infection including abcesses or fistulae;
HIV+ patients;
Pregnant or lactating females;
Patients who have had radiation, chemotherapy, or hormonal therapy within the last four (4) weeks excluding palliative radiotherapy to isolated peripheral bone metastases not being used as markers for efficacy;
Patients taking Herceptin less than three (3) weeks prior to study start.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035126

Locations


United States, New Hampshire
	Dartmouth Hitchcock Medical Center
	Lebanon, New Hampshire, United States, 03756

United States, New Jersey
	Cancer Institute of New Jersey (CINJ)
	New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Study ID Numbers:	CEPO906A2205
First Received:	May 2, 2002
Last Updated:	August 15, 2006
ClinicalTrials.gov Identifier:	NCT00035126
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

breast

cancer

tumor

tumour

intravenous

epothilone

taxane

anthracycline

Study placed in the following topic categories:

Epothilone B

Skin Diseases

Epothilones

Breast Neoplasms

Taxane

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Antimitotic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00035126