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EPO906 Therapy in Patients With Advanced Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00035243
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : April 17, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Neoplasms Drug: epothilone b Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2002
Primary Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: every 8 weeks ]
  2. Time to disease progression (TTP) [ Time Frame: every 8 weeks ]
  3. Overall Survival (OS) [ Time Frame: every 8 weeks ]
  4. Safety and tolerability of EPO906 [ Time Frame: at each visit ]
  5. Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma [ Time Frame: prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment ]
    For biomarker development

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035243

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
Centre L. Berard
Lyon, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00035243     History of Changes
Obsolete Identifiers: NCT00041002
Other Study ID Numbers: CEPO906A2207
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
kidney cancer
renal cancer
clear cell
collecting duct

Additional relevant MeSH terms:
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents