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EPO906 Therapy in Patients With Advanced Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00035243
First received: May 2, 2002
Last updated: April 16, 2012
Last verified: April 2012
  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 2

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:


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:
  • Objective response rate (ORR) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Time to disease progression (TTP) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability of EPO906 [ Time Frame: at each visit ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    For biomarker development


Enrollment: 53
Study Start Date: April 2002
Primary Completion Date: August 2003 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00035243     History of Changes
Obsolete Identifiers: NCT00041002
Other Study ID Numbers: CEPO906A2207
Study First Received: May 2, 2002
Last Updated: April 16, 2012
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:
Kidney Neoplasms
Neoplasms
Kidney Diseases
Neoplasms by Site
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Epothilone B
Epothilones
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014