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BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
This study has been withdrawn prior to recruitment.
First Received: July 8, 2002   Last Updated: January 11, 2007   History of Changes
Sponsor: Jonsson Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00040989
  Purpose

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 Intervention Phase
Stage IV Renal Cell Cancer
Recurrent Renal Cell Cancer
Drug: BAY 56-3722
Procedure: enzyme inhibitor therapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


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

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040989

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Florida
Oncology-Hematology Group of South Florida
Miami, Florida, United States, 33176
United States, Georgia
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7353
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642-0001
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Cancer Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229-3264
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Barbara J. Gitlitz, MD Jonsson Comprehensive Cancer Center
  More Information

No publications provided

Study ID Numbers: CDR0000069432, UCLA-0201019, UTHSC-0125011152, BAYER-100364, NCI-G02-2090
Study First Received: July 8, 2002
Last Updated: January 11, 2007
ClinicalTrials.gov Identifier: NCT00040989     History of Changes
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Disease Attributes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Pharmacologic Actions
Recurrence
Carcinoma
Neoplasms
Pathologic Processes
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009