Status:
COMPLETED
Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 we...
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 onc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00459875
Start Date
March 1 2007
End Date
November 1 2010
Last Update
November 26 2015
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065