NCT00035243

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Last Updated

April 17, 2012

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

May 2, 2002

Last Update Submit

April 16, 2012

Conditions

Kidney Neoplasms

Keywords

kidney cancerrenal cancercancertumortumourneoplasmcarcinomaclear cellsarcomatoidpapillarymedullarycollecting ductchromophobeintravenousepothilone

Outcome Measures

Primary Outcomes (1)

  • Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

    every 8 weeks

Secondary Outcomes (5)

  • Objective response rate (ORR)

    every 8 weeks

  • Time to disease progression (TTP)

    every 8 weeks

  • Overall Survival (OS)

    every 8 weeks

  • Safety and tolerability of EPO906

    at each visit

  • Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma

    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

Study Arms (1)

EPO906

EXPERIMENTAL
Drug: epothilone b

Interventions

epothilone bDRUG

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.

EPO906

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Wayne State University Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Our Lady Of Mercy Medical Center

The Bronx, New York, 10466, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Centre L. Berard

Lyon, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Links

MeSH Terms

Conditions

Kidney NeoplasmsNeoplasmsCarcinoma

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 3, 2002

Study Start

April 1, 2002

Primary Completion

August 1, 2003

Last Updated

April 17, 2012

Record last verified: 2012-04

Locations

US(6)FR(2)