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

Inclusion Criteria

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