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A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Naomi S. Balzer-Haas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

Unspecified

Study ID:

CDR0000681614

NCT ID:

NCT01164228

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • clear cell renal cell carcinoma
  • papillary renal cell carcinoma
  • clear cell sarcoma of the kidney
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Northern New JerseyHackensack, New Jersey  07601
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
St. Rita's Medical CenterLima, Ohio  45801
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Beth Israel Medical Center - Petrie DivisionNew York, New York  10003-3803
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Hematology and Oncology AssociatesChicago, Illinois  60611
Eureka Community HospitalEureka, Illinois  61530
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Stanford Cancer CenterStanford, California  94305-5824
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Kellogg Cancer Care CenterHighland Park, Illinois  60035
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Galesburg Clinic, PCGalesburg, Illinois  61401
Provena St. Mary's Regional Cancer Center - KankakeeKankakee, Illinois  60901
Cancer Center of Kansas, PA - McPhersonMcPherson, Kansas  67460