Phase II Study of Sunitinib in Patients With Metastatic Papillary Renal Cell Carcinoma
Phase II Study of Sunitinib in Patients With Metastatic Papillary Renal Cell Carcinoma
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with locally recurrent or metastatic kidney cancer.
OBJECTIVES:
Primary
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 28 days and every 2 months thereafter.
DISEASE CHARACTERISTICS:
Histologically confirmed advanced renal cell carcinoma of papillary or other non-clear cell histology
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
The following are considered nonmeasurable disease:
Patients with primary tumor in place who are eligible for surgery must have undergone prior partial or radical nephrectomy
No history of or known brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis
PATIENT CHARACTERISTICS:
Karnofsky performance status 70-100%
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9.0 g/dL
Calcium ≤ 12.0 mg/dL
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
AST and ALT ≤ 2.5 times ULN (5 times ULN if liver function abnormalities are due to underlying malignancy)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No hemorrhage ≥ grade 3 within the past 4 weeks
No diagnosis of any second malignancy within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
None of the following within the past 6 months:
No ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade
No prolongation of the QTc interval to > 450 msec (males) or > 470 msec (females)
No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite optimal medical therapy)
No pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication
No known HIV or AIDS-related illness
No other active infection
No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior sunitinib malate
Prior or concurrent bisphosphonates allowed
More than 4 weeks since prior radiotherapy and recovered
Prior palliative radiotherapy to metastatic lesions allowed provided there is ≥ 1 measurable lesion that has not been irradiated
More than 4 weeks since prior major surgery and recovered
No concurrent therapeutic doses of warfarin
No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy
No other concurrent investigational drugs
No concurrent treatment on another clinical trial