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

Primary Purpose

Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BAY 56-3722
enzyme inhibitor therapy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Renal Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Jonsson Comprehensive Cancer Center, UCLA
  • University of Colorado Cancer Center
  • Oncology-Hematology Group of South Florida
  • Emory University Hospital - Atlanta
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Dwight David Eisenhower Army Medical Center
  • Loyola University Medical Center
  • University of Kansas Medical Center
  • Tulane University School of Medicine
  • Louisiana State University Health Sciences Center - Shreveport
  • Dana-Farber Cancer Institute
  • Ellis Fischel Cancer Center - Columbia
  • University of Nebraska Medical Center
  • Norris Cotton Cancer Center
  • Hackensack University Medical Center
  • Cancer Institute of New Jersey
  • University of Rochester Medical Center
  • Cleveland Clinic Taussig Cancer Center
  • Oregon Cancer Institute
  • University of Pennsylvania Cancer Center
  • Cancer Centers of the Carolinas
  • Simmons Cancer Center - Dallas
  • Baylor College of Medicine
  • Cancer Therapy and Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2002
Last Updated
July 9, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00040989
Brief Title
BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
Official Title
Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BAY 56-3722
Intervention Type
Procedure
Intervention Name(s)
enzyme inhibitor therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J. Gitlitz, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Oncology-Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Dwight David Eisenhower Army Medical Center
City
Fort Gordon
State/Province
Georgia
ZIP/Postal Code
30905-5650
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7353
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3264
Country
United States

12. IPD Sharing Statement

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

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