EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer - Full Text View

Purpose

This study will examine whether the new 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 ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.

Condition	Intervention	Phase
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms	Drug: epothilone b	Phase II

MedlinePlus related topics:

Cancer Ovarian Cancer

Drug Information available for:

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 Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

Further study details as provided by Novartis:

Primary Outcome Measures:

Maximum tolerated dose

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 the study:

Histologically or cytologically documented evidence of ovarian, primary Fallopian or primary peritoneal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
Must have a life expectancy of greater than three (3) months
Prior failure to respond following front-line treatment with a taxane and platinum (or a combination therapy) may be eligible.

Exclusion Criteria

The following patients are not eligible for the study:

Patients with radiation therapy or chemotherapy within the last four weeks
Patients who have had any chemotherapy not containing a taxane and platinum for their disease
Patients with borderline ovarian and macropapillary tumors
Patients with unresolved bowel obstruction
Patients with symptomatic CNS metastases or leptomeningeal involvement
Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
Patients with 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 skin cancer or cervical cancer in situ
Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
HIV+ patients
Pregnant or lactating females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035100

Locations


United States, California
	California Pacific Medical Center
	San Francisco, California, United States, 94116

United States, Connecticut
	St. Francis Hospital
	Hartford, Connecticut, United States, 06105

United States, Maryland
	The Sidney Kimmel Comprehensive Cancer Center
	Baltimore, Maryland, United States, 21287

United States, Nevada
	Women's Cancer Center of Nevada
	Las Vegas, Nevada, United States, 89109

United States, Rhode Island
	Women and Infants Hospital
	Providence, Rhode Island, United States, 02905

United States, Tennessee
	Sarah Cannon Cancer Center
	Nashville, Tennessee, United States, 37203

United States, Utah
	Huntsman Cancer Institute, University of Utah
	Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Study ID Numbers:	CEPO906A2203
First Received:	May 2, 2002
Last Updated:	January 25, 2008
ClinicalTrials.gov Identifier:	NCT00035100
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

ovarian

ovary

peritoneal cancer

fallopian cancer

cancer

tumor

tumour

neoplasm

carcinoma

intravenous

epothilone

Study placed in the following topic categories:

Ovarian cancer

Epothilone B

Digestive System Neoplasms

Ovarian Neoplasms

Gonadal Disorders

Epothilones

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Ovarian Diseases

Abdominal Neoplasms

Fallopian Tube Neoplasms

Carcinoma

Fallopian Tube Diseases

Genital Diseases, Female

Digestive System Diseases

Peritoneal Diseases

Gastrointestinal Neoplasms

Endocrinopathy

Fallopian tube cancer

Peritoneal Neoplasms

Endocrine Gland Neoplasms

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

Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00035100