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An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer


Phase 2
18 Years
85 Years
Not Enrolling
Both
Kidney Neoplasms

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Trial Information

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

every 8 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CEPO906A2207

NCT ID:

NCT00035243

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Kidney Neoplasms
  • kidney cancer
  • renal cancer
  • cancer
  • tumor
  • tumour
  • neoplasm
  • carcinoma
  • clear cell
  • sarcomatoid
  • papillary
  • medullary
  • collecting duct
  • chromophobe
  • intravenous
  • epothilone
  • Neoplasms
  • Kidney Neoplasms

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Our Lady of Mercy Medical CenterBronx, New York  10466
University of WashingtonSeattle, Washington  98195
UCLA Medical CenterLos Angeles, California  90095-7059
University of MarylandBaltimore, Maryland  21201
Wayne State University Karmanos Cancer CenterDetroit, Michigan  48201