Chemotherapy in Treating Patients With Metastatic Kidney Cancer

Sponsor
Theradex (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00024388
Collaborator
(none)
7

Study Details

Study Description

Brief Summary

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 DHA-paclitaxel in treating patients who have locally advanced, metastatic, or unresectable kidney cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES: I. Determine the tumor response rate, duration of response, and time to disease progression in patients with locally advanced, metastatic, or unresectable renal cell cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day

  1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at completion of treatment. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion In Patients With Metastatic, Locally Advanced, or Unresectable Renal Cell Carcinoma
Study Start Date :
Apr 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed renal cell cancer Locally advanced OR Metastatic OR Unresectable Measurable disease No known or clinical evidence of CNS metastasis

    PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months No superior vena cava syndrome Neurologic: No peripheral neuropathy greater than grade 1 No uncontrolled major seizure disorder No spinal cord compression Other: No other prior malignancy except: Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR Cancer curatively treated with surgery alone that has not recurred for more than 5 years No concurrent serious infection requiring parenteral therapy No unstable or serious concurrent medical conditions No psychiatric disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study

    PRIOR CONCURRENT THERAPY: Biologic therapy: At least 28 days since prior immunotherapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy for advanced disease No prior taxanes At least 28 days since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least 28 days since prior hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 28 days since prior large-field radiotherapy No concurrent radiotherapy Surgery: At least 14 days since prior major surgery Other: Concurrent bisphosphonates allowed if on stable dose for at least 30 days prior to study No other concurrent anticancer therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology Associates Tucson Arizona United States 85712-2254
    2 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    3 Lucille Parker Markey Cancer Center, University of Kentucky Lexington Kentucky United States 40536-0093
    4 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    5 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    6 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    7 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • Theradex

    Investigators

    • Study Chair: Ronald M. Bukowski, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00024388
    Other Study ID Numbers:
    • CDR0000068928
    • THERADEX-P01-00-07
    • CCF-IRB-4046
    • PROTARGA-P01-00-07
    First Posted:
    Jan 14, 2004
    Last Update Posted:
    Jul 24, 2008
    Last Verified:
    Jun 1, 2002

    Study Results

    No Results Posted as of Jul 24, 2008