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

Stage IV Renal Cell Cancer Clinical Trial

Official title:

Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00040989
• Other study ID #: UCLA-0201019
• Secondary ID: CDR0000069432UTH
• Status: Withdrawn
• Phase: Phase 2
• First received: July 8, 2002
• Last updated: July 9, 2013

Study information

• Verified date: December 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Recurrent Renal Cell Cancer
• Stage IV Renal Cell Cancer

Intervention

Drug:
• BAY 56-3722

Procedure:
• enzyme inhibitor therapy

Locations

Country	Name	City	State
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Baylor College of Medicine	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Oncology-Hematology Group of South Florida	Miami	Florida
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Oregon Cancer Institute	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,