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EPO906 Therapy in Patients With Advanced Kidney Cancer
This study has been completed.
First Received: May 2, 2002   Last Updated: September 18, 2007   History of Changes
Sponsored by: Novartis
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: 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 Renal Cancer

Resource links provided by NLM:


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:   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
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Study ID Numbers: CEPO906A2207
Study First Received: May 2, 2002
Last Updated: September 18, 2007
ClinicalTrials.gov Identifier: NCT00035243     History of Changes
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

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Epothilone B
Epothilones
Urogenital Neoplasms
Antimitotic Agents
Urologic Neoplasms
Carcinoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Tubulin Modulators
Carcinoma, Renal Cell
Kidney Diseases

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

ClinicalTrials.gov processed this record on September 11, 2009