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BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00040989
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
26
Locations
0
Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: BAY 56-3722
  • Procedure: enzyme inhibitor therapy
 Phase 2

Detailed Description

OBJECTIVES:

  • Determine the tumor response rate of patients with recurrent, unresectable, or metastatic renal cell carcinoma treated with BAY 56-3722.

  • Determine the duration of response, time to progression, and survival of patients treated with this drug.

  • Determine the qualitative and quantitative toxic effects of this drug in these patients.

  • Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Primary Purpose:
Treatment
Official Title:
Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma

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 confirmed renal cell carcinoma (RCC)

    • Recurrent AND unresectable disease OR

    • Unresectable disease OR

    • Metastatic disease

    • At least 1 bidimensionally measurable lesion by CT scan or MRI

    • No metastatic brain or meningeal tumors unless more than 3 months since prior surgery and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4 weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • At least 12 weeks
    Hematopoietic:

    • Absolute neutrophil count at least 1,500/mm^3

    • Platelet count at least 100,000/mm^3

    • Hemoglobin at least 9 g/dL

    Hepatic:

    • Bilirubin no greater 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)

    • No chronic hepatitis B or C

    Renal:

    • Creatinine no greater than 1.5 mg/dL

    • Calcium normal

    Cardiovascular:

    • No clinically evident congestive heart failure

    • No serious cardiac arrhythmias

    • No symptoms of coronary heart disease

    • No symptoms of ischemia

    Other:

    • HIV negative

    • No active infections requiring systemic antibacterial, antifungal, or antiviral therapy

    • No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1)

    • No substance abuse

    • No medical, psychological, or social conditions that would preclude study

    • No known or suspected allergy to study drug or any other study agents

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for at least 6 months after study

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • No prior anticancer vaccine therapy

    • No prior bone marrow transplantation or stem cell rescue

    • More than 4 weeks since prior thalidomide and bevacizumab

    • At least 4 weeks since prior interleukin-2 and interferon

    • No more than 2 prior regimens

    • No concurrent bone marrow transplantation or stem cell rescue

    Chemotherapy:

    • No prior cytotoxic chemotherapy

    • No concurrent cytotoxic chemotherapy

    Endocrine therapy:

    • See Disease Characteristics

    • No prior hormonal therapy for RCC

    • No concurrent hormonal therapy for RCC

    Radiotherapy:

    • See Disease Characteristics

    • More than 4 weeks since prior radiotherapy

    • No prior radiotherapy to indicator lesion unless progression is documented

    Surgery:

    • See Disease Characteristics

    • More than 3 weeks since prior major surgery

    Other:

    • At least 4 weeks since prior investigational anticancer drugs

    • No other concurrent investigational anticancer drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    3 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    4 University of Colorado Cancer Center Denver Colorado United States 80010
    5 Oncology-Hematology Group of South Florida Miami Florida United States 33176
    6 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    7 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
    8 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    9 Loyola University Medical Center Maywood Illinois United States 60153
    10 University of Kansas Medical Center Kansas City Kansas United States 66160-7353
    11 Tulane University School of Medicine New Orleans Louisiana United States 70112
    12 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    13 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    14 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    15 University of Nebraska Medical Center Omaha Nebraska United States 68198-3330
    16 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
    17 Hackensack University Medical Center Hackensack New Jersey United States 07601
    18 Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    19 University of Rochester Medical Center Rochester New York United States 14642-0001
    20 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    21 Oregon Cancer Institute Portland Oregon United States 97239
    22 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    23 Cancer Centers of the Carolinas Greenville South Carolina United States 29615
    24 Simmons Cancer Center - Dallas Dallas Texas United States 75390
    25 Baylor College of Medicine Houston Texas United States 77030
    26 Cancer Therapy and Research Center San Antonio Texas United States 78229-3264

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Barbara J. Gitlitz, MD, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00040989
    Other Study ID Numbers:
    • UCLA-0201019
    • CDR0000069432
    • UTHSC-0125011152
    • BAYER-100364
    • NCI-G02-2090
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 10, 2013
    Last Verified:
    Dec 1, 2006
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell
    Recurrence
    Enzyme Inhibitors

    Study Results

    No Results Posted as of Jul 10, 2013