Kidney Cancer
Conditions
Keywords
recurrent renal cell cancer, stage IV renal cell cancer
Brief summary
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.
Detailed description
OBJECTIVES: Primary * Determine the efficacy of sunitinib malate in patients with locally recurrent or metastatic papillary renal cell carcinoma. 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed advanced renal cell carcinoma of papillary or other non-clear cell histology * Metastatic or locally recurrent disease * 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: * Bone lesions * Ascites * Peritoneal carcinomatosis or miliary lesions * Pleural or pericardial effusions * Lymphangitis of the skin or lung * Cystic lesions * Irradiated lesions * 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: * Myocardial infarction * Severe or unstable angina * Coronary or peripheral artery bypass graft * Symptomatic congestive heart failure * Cerebrovascular accident or transient ischemic attack * Pulmonary embolism * 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 * Low-dose warfarin ≤ 2 mg daily for thromboprophylaxis allowed * Concurrent low molecular weight heparin for full anticoagulation allowed * 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 * Concurrent participation on supportive care trials or nontreatment trials (e.g., quality of life trials) allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Objective Response Rate as Measured by RECIST | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.
sunitinib malate | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Ineligible participant | 1 |
Baseline characteristics
| Characteristic | Sunitinib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 23 |
| serious Total, serious adverse events | 11 / 23 |
Outcome results
Overall Objective Response Rate as Measured by RECIST
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Overall Objective Response Rate as Measured by RECIST | Stable Disease (SD) | 16 participants |
| Sunitinib | Overall Objective Response Rate as Measured by RECIST | Progression of Disease (POD) | 6 participants |
| Sunitinib | Overall Objective Response Rate as Measured by RECIST | Partial Response (PR) | 1 participants |