Full Text View
Tabular View
No Study Results Posted
Related Studies
Epothilone B in Treating Patients With Advanced Kidney Cancer
This study has been completed.
Study NCT00041002   Information provided by National Cancer Institute (NCI)
First Received: July 8, 2002   Last Updated: February 6, 2009   History of Changes

July 8, 2002
February 6, 2009
April 2002
 
 
 
Complete list of historical versions of study NCT00041002 on ClinicalTrials.gov Archive Site
 
 
 
Epothilone B in Treating Patients With Advanced Kidney Cancer
An Open Label Phase IIa Trial Evaluating The Safety And Efficacy Of EP0906 As Therapy In Patients With Advanced Renal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of epothilone B in treating patients who have advanced kidney cancer.

OBJECTIVES:

  • Determine whether epothilone B can produce a significant response (complete response (CR) or partial response (PR)) as measured by tumor shrinkage in patients with advanced renal cancer.
  • Determine the objective response rate and duration of response in patients with CR or PR after treatment with this drug.
  • Determine the time to disease progression and overall survival in patients treated with this drug.
  • Determine the safety and tolerability of this drug in these patients.
  • Determine genetic factors related to renal cancer that may predict response in patients treated with this drug.
  • Determine relative susceptibility to drug-drug interactions or serious side effects in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive epothilone B IV over 5 minutes once weekly for three weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 week and then every three months thereafter.

PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
Kidney Cancer
Biological: epothilone B
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed epithelial renal cell carcinoma

    • Clear cell
    • Sarcomatoid
    • Papillary
    • Medullary
    • Collecting duct
    • Chromophobe
    • Mixed histology
  • Progressive regional disease or metastatic disease
  • Prior nephrectomy required
  • Previously untreated patients or patients who have received no more than one prior cytokine regimen (interleukin-2, interferon alfa, or a combination of these agents) and have failed or relapsed within 8 months of treatment
  • At least one measurable lesion

    • Patients who have received prior radiotherapy to the marker lesion(s) must have disease progression in that lesion since treatment
  • No CNS metastases or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC greater than 3,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Hemoglobin greater than 9.0 g/dL
  • Platelet count greater than 100,000/mm^3
  • Red blood cell transfusions allowed

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase less than 2.5 times ULN

Renal:

  • Creatinine less than 1.5 times ULN

Cardiovascular:

  • No severe cardiac insufficiency
  • No New York Heart Association class III or IV disease
  • No uncontrolled and/or unstable cardiac or coronary artery disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study therapy
  • No peripheral neuropathy greater than grade 1
  • No unresolved diarrhea greater than grade 1
  • No active or suspected acute or chronic uncontrolled infection
  • No abscess or fistula
  • HIV negative
  • No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer, prostate cancer, or carcinoma in situ of the cervix
  • No prior noncompliance to medical regimens
  • No history of severe medical conditions that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery

Other:

  • More than 28 days since prior investigational drugs
  • No other concurrent investigational drugs
  • No concurrent warfarin or other agents containing warfarin except low-dose warfarin (1 mg or less) administered prophylactically for maintenance of indwelling lines or ports
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00041002
 
CDR0000069433, UCLA-0202045, NOVARTIS-CEP0906A2207, NCI-G02-2091
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert A. Figlin, MD, FACP Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP