Status:
COMPLETED
Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
ECOG-ACRIN Cancer Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcit...
Detailed Description
OBJECTIVES: Primary * To evaluate the response rate to sunitinib malate with vs without gemcitabine hydrochloride in patients with advanced renal cell carcinoma with sarcomatoid features. Secondary...
Eligibility Criteria
Inclusion
- Histologically confirmed\* renal cell carcinoma of any subtype containing any sarcomatoid features NOTE: \*Patients must have a paraffin-embedded tumor specimen from the kidney or metastatic site available for central review and confirmation of tumor histology
- Measurable advanced disease that is not resectable by surgery
- Patients with resected or radiated brain metastases or those treated with stereotactic radiation therapy are eligible, provided they have been off steroids for at least 2 weeks
- More than 2 weeks since prior radiotherapy and recovered
- Previously irradiated lesions must not be the sole site of disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
- Serum creatinine clearance ≥ 30 mL/min
- serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal (ULN; ≤ 5 times ULN in the presence of liver metastases)
- Total bilirubin ≤ 1.5 times ULN
- Baseline corrected QT interval \< 500 msec on EKG
- Able to swallow pills
- Negative pregnancy test
- Fertile patients must use effective contraception before and during study treatment
- More than 2 weeks since prior and no concurrent ketoconazole, dexamethasone, dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study
Exclusion
- Collecting duct or medullary carcinoma
- Prior systemic therapy for metastatic disease. One prior therapeutic regimen with a non-tyrosine kinase inhibitor, such as an mtor inhibitor is allowed. Patients who were randomized to placebo on an adjuvant study are eligible
- History of stroke within the past 6 months.
- Pregnant or nursing
- Clinically significant cardiovascular disease, defined as one of the following:
- Uncontrolled hypertension (blood pressure \> 150/100 mm Hg at the time of enrollment); patients with hypertension and BP ≤ 150/100 mm Hg on stable antihypertensive regimen are eligible
- History of myocardial infarction or unstable angina within the past 24 weeks
- New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris
- Peripheral vascular disease ≥ grade II
- Ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
- History of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation \> 3 beats in a row)
- Ongoing atrial fibrillation
- Pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained at less than or within the normal range with medication
- Serious concurrent illness or active infection that would jeopardize the ability of the patient to receive study treatment
- Known HIV
Key Trial Info
Start Date :
September 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01164228
Start Date
September 17 2010
End Date
November 3 2021
Last Update
June 15 2023
Active Locations (99)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
3
Stanford Cancer Center
Stanford, California, United States, 94305-5824
4
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105