Phase II Study of Sunitinib in Patients With Metastatic Papillary Renal Cell Carcinoma
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| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10065 |
| Conditions: |
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Kidney Cancer |
| Purpose: |
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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.
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| Study Summary: |
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OBJECTIVES:
Primary
- Determine the efficacy of sunitinib malate in patients with locally recurrent or
metastatic papillary renal cell carcinoma.
Secondary
- Determine the safety of this drug in these patients.
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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00459875 |
| Primary Contact: |
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Principal Investigator
Glenn Kroog, MD
Memorial Sloan-Kettering Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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New York, New York 10065
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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