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Epothilone B in Treating Patients With Advanced Kidney Cancer
This study has been completed.
First Received: July 8, 2002   Last Updated: 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: Treatment, Open Label
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

Study ID Numbers: CDR0000069433, UCLA-0202045, NOVARTIS-CEP0906A2207, NCI-G02-2091
Study First Received: July 8, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00041002     History of Changes
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:
Epothilone B
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Epothilones
Mitosis Modulators
Urogenital Neoplasms
Antimitotic Agents
Urologic Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Tubulin Modulators
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009