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

Overview

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.

Full Title of Study: “Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment

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.

Interventions

  • Drug: BAY 56-3722
  • Procedure: enzyme inhibitor therapy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jonsson Comprehensive Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Overall Official(s)
    • Barbara J. Gitlitz, MD, Study Chair, Jonsson Comprehensive Cancer Center

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