This trial is active, not recruiting.

Condition kidney cancer
Treatments gemcitabine hydrochloride, sunitinib malate
Phase phase 2
Targets VEGF, PDGF, FLT-3, KIT
Sponsor Eastern Cooperative Oncology Group
Collaborator National Cancer Institute (NCI)
Start date June 2010
End date June 2021
Trial size 100 participants
Trial identifier NCT01164228, CDR0000681614, ECOG-E1808


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.

United States Alabama, California, Illinois, Indiana, Iowa, Kansas, Maryland, Michigan, New Jersey, and Ohio
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking open label
Primary purpose treatment
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35.
gemcitabine hydrochloride
Given IV
sunitinib malate
(Active Comparator)
Patients receive oral sunitinib malate once daily on days 1-14 and 22-35.
sunitinib malate

Primary Outcomes

Response rate
time frame:

Secondary Outcomes

Progression-free survival
time frame:
Overall survival
time frame:
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed* renal cell carcinoma - Disease of any subtype allowed - Disease must have 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 - No collecting duct or medullary carcinoma - 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 PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - AGC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9.0 g/dL (transfusions allowed) - Serum creatinine clearance ≥ 30 mL/min - SGOT and SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases) - Total bilirubin ≤ 1.5 times ULN - Baseline QTc interval < 500 msec on EKG - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception before and during study treatment - Able to swallow pills - No history of stroke within the past 6 months - No clinically significant cardiovascular disease, defined as one of the following: - Uncontrolled hypertension (BP > 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 - NYHA class II-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris - Peripheral vascular disease ≥ grade II - No ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by NCI CTCAE version 4 - No patients with a history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation > 3 beats in a row) - No patients with ongoing atrial fibrillation - No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained at less than or within the normal range with medication - No serious concurrent illness or active infection that would jeopardize the ability of the patient to receive study treatment - No known HIV - 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 PRIOR CONCURRENT THERAPY: - No prior systemic therapy for metastatic disease - Patients who were randomized to placebo on an adjuvant study are eligible - More than 2 weeks since prior radiotherapy and recovered - Previously irradiated lesions must not be the sole site of disease - 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 - Topical and inhaled steroids are allowed

Additional Information

Official title A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features
Principal investigator Naomi S. Balzer-Haas, MD
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 - To evaluate progression-free survival of these patients. - To evaluate overall survival of these patients. - To describe the toxic effects of both sunitinib malate alone and in combination with gemcitabine hydrochloride in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [clear cell and < 20% sarcomatoid and performance status (PS) 0] vs intermediate risk [20-50% sarcomatoid and PS 0] vs poor risk [non-clear cell or > 50% sarcomatoid or PS 1 or non-clear cell]). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. - Arm II: Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. In both arms, courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 100 patients (60 in arm I and 40 in arm II) will be accrued to this study.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Eastern Cooperative Oncology Group.
Location data was received from the National Cancer Institute and was last updated in April 2016.