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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer

Intervention / Treatment
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* Drug: BAY 56-3722
* Procedure: enzyme inhibitor therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BAY 56-3722|nan|
|Procedure: enzyme inhibitor therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |