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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00035100

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Epothilone B

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Maximum tolerated dose

Secondary Outcome Measures:

Time to progression [ Time Frame: Every 6 week while on study ]
Overall survival [ Time Frame: Every 3 months ]

Enrollment:	112
Study Start Date:	September 2001
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: EPO906	Drug: epothilone b Other Name: EPO906

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 Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00035100 History of Changes
Other Study ID Numbers:	CEPO906A2203
Study First Received:	May 2, 2002
Last Updated:	March 24, 2011
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

Additional relevant MeSH terms:

Neoplasms
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders

Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Epothilone B
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012