BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
NCT ID: NCT00040989
Last Updated: 2013-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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BAY 56-3722
enzyme inhibitor therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Principal Investigators
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Barbara J. Gitlitz, MD
Role: STUDY_CHAIR
Jonsson Comprehensive Cancer Center
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Oncology-Hematology Group of South Florida
Miami, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Rochester Medical Center
Rochester, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Oregon Cancer Institute
Portland, Oregon, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
Countries
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Other Identifiers
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CDR0000069432
Identifier Type: REGISTRY
Identifier Source: secondary_id
UTHSC-0125011152
Identifier Type: -
Identifier Source: secondary_id
BAYER-100364
Identifier Type: -
Identifier Source: secondary_id
NCI-G02-2090
Identifier Type: -
Identifier Source: secondary_id
UCLA-0201019
Identifier Type: -
Identifier Source: org_study_id
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