EPO906 Therapy in Patients With Advanced Kidney Cancer
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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:
|
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 May 19, 2013