Clinical trial NCT00035243: EPO906 Therapy in Patients With Advanced Kidney Cancer
Official title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Neoplasms
Keywords: kidney cancer
renal cancer
cancer
tumor
tumour
neoplasm
carcinoma
clear cell
sarcomatoid
papillary
medullary
collecting duct
chromophobe
intravenous
epothilone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: every 8 weeks
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: every 8 weeks
measure: Time to disease progression (TTP)
timeFrame: every 8 weeks
measure: Overall Survival (OS)
timeFrame: every 8 weeks
measure: Safety and tolerability of EPO906
timeFrame: at each visit
measure: Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma
timeFrame: 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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Wayne State University Karmanos Cancer Center
state: Michigan
city: Bronx
country: United States
facility: Our Lady Of Mercy Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Lyon
country: France
facility: Centre L. Berard
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: