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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00040989
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : July 10, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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
Stage IV Renal Cell Cancer Recurrent Renal Cell Cancer Drug: BAY 56-3722 Procedure: enzyme inhibitor therapy Phase 2

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • 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


  • Creatinine no greater than 1.5 mg/dL
  • Calcium normal


  • No clinically evident congestive heart failure
  • No serious cardiac arrhythmias
  • No symptoms of coronary heart disease
  • No symptoms of ischemia


  • 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


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


  • 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


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to indicator lesion unless progression is documented


  • See Disease Characteristics
  • More than 3 weeks since prior major surgery


  • At least 4 weeks since prior investigational anticancer drugs
  • No other concurrent investigational anticancer drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00040989

  Show 26 Study Locations
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Barbara J. Gitlitz, MD Jonsson Comprehensive Cancer Center Identifier: NCT00040989     History of Changes
Other Study ID Numbers: UCLA-0201019
CDR0000069432 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: December 2006

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors