Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery

Completed · Phase 2

Conditions studied: Kidney Cancer

In brief

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 gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer. PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery.

Key facts

Study ID

NCT01164228

Run by

ECOG-ACRIN Cancer Research Group

People needed

87

Starts

2010-09-17

Expected to finish

2021-11-03

Last updated by the study team

2023-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Stanford Cancer Center — Stanford, California, United States
• Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• St. Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• Hematology and Oncology Associates — Chicago, Illinois, United States
• Eureka Community Hospital — Eureka, Illinois, United States
• Galesburg Clinic, PC — Galesburg, Illinois, United States
• Kellogg Cancer Care Center — Highland Park, Illinois, United States
• Provena St. Mary's Regional Cancer Center - Kankakee — Kankakee, Illinois, United States
• North Shore Oncology and Hematology Associates, Limited - Libertyville — Libertyville, Illinois, United States
• McDonough District Hospital — Macomb, Illinois, United States
• Cancer Care and Hematology Specialists of Chicagoland - Niles — Niles, Illinois, United States
• BroMenn Regional Medical Center — Normal, Illinois, United States
• Community Cancer Center — Normal, Illinois, United States
• Community Hospital of Ottawa — Ottawa, Illinois, United States
• Cancer Treatment Center at Pekin Hospital — Pekin, Illinois, United States
• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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