EPO906 Therapy in Patients With Advanced Kidney Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2009 by Novartis. Recruitment status was Active, not recruiting

First Received on May 2, 2002. Last Updated on November 12, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00035243

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 kidney cancer.

Condition	Intervention	Phase
Kidney 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 Renal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Epothilone B

U.S. FDA Resources

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) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	53
Study Start Date:	October 2007
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: EPO906	Drug: epothilone b EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues.

Eligibility

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

Criteria

Inclusion Criteria:

The following patients may be eligible for this study:

Histologically or cytologically documented evidence of epithelial renal cell carcinoma with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
Patients must have had a prior nephrectomy
Must have a life expectancy of greater than three (3) months
Patients who have had 0-1 prior cytokine treatment regimen (i.e. IL-2, IFN-?) or relapsed less than one year after such treatment may be eligible.

Exclusion Criteria:

The following patients are not eligible for this study:

Patients who have received more than one (1) prior cytokine regimen (i.e. IL-2, IFN?) or relapsed more than one year after receiving such treatment are not eligible
Patients who have had any prior chemotherapy (including a combination therapy)
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 3 years prior to study entry except curatively treated non-melanoma skin cancer, prostate 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: NCT00035243

Locations

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Wayne State University Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, New York
Our Lady Of Mercy Medical Center
Bronx, New York, United States, 10466
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
France
Centre L. Berard
Lyon, France
Institut Gustave Roussy
Villejuif, France

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00035243 History of Changes
Other Study ID Numbers:	CEPO906A2207
Study First Received:	May 2, 2002
Last Updated:	November 12, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

kidney cancer
renal cancer
cancer
tumor
tumour
neoplasm
carcinoma
clear cell

sarcomatoid
papillary
medullary
collecting duct
chromophobe
intravenous
epothilone

Additional relevant MeSH terms:

Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic 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 09, 2012