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Epothilone B in Treating Patients With Advanced Kidney Cancer
This study has been completed.

First Received on July 8, 2002.   Last Updated on February 6, 2009   History of Changes
Sponsor: Jonsson Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041002
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Biological: epothilone B
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase IIa Trial Evaluating The Safety And Efficacy Of EP0906 As Therapy In Patients With Advanced Renal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041002

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-5907
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Robert A. Figlin, MD, FACP Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00041002     History of Changes
Other Study ID Numbers: CDR0000069433, UCLA-0202045, NOVARTIS-CEP0906A2207, NCI-G02-2091
Study First Received: July 8, 2002
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
clear cell renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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 February 09, 2012