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

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

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.

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.

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