Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients With Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
PRIMARY OBJECTIVES:
I. To evaluate disease-free survival, defined as the time from randomization to the
development of recurrent disease, second primary cancer (other than localized breast,
localized prostate, or non-melanoma skin cancer), or death from any cause, of patients with
metastatic renal cell carcinoma (RCC) with no evidence of disease following metastasectomy
with pazopanib hydrochloride (pazopanib) as compared to placebo.
SECONDARY OBJECTIVES:
I. To describe the overall survival of patients with advanced RCC randomly assigned to
receive placebo or pazopanib for one year following metastasectomy to no evidence of disease
(NED).
II. To describe treatment- and (at recurrence) disease-related adverse events in the two
treatment arms III. To analyze quality-adjusted time without symptoms of disease or
treatment (Q-TWiST) for subjects in the two treatment arms.
IV. To characterize changes in patient-reported fatigue and (at recurrence) kidney
cancer-related symptoms during and following treatment with pazopanib compared to placebo.
V. To explore the association between plasma trough levels of pazopanib and disease-free and
overall survival.
VI. To prospectively bank preserved tissue from primary tumors and associated metastatic
sites in patients with RCC.
OUTLINE: Patients are randomized to 1of 2 treatment arms.
ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28.
Treatment repeats every 28 days for up to 13 courses in the absence of disease progression
or unacceptable toxicity.
ARM II: Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up
to 13 courses in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood sample collection at baseline and periodically during treatment
for pharmacokinetic and future correlative studies. Tumor tissue samples may also be
collected. Patients complete questionnaires related to mobility, self-care, usual
activities, pain/discomfort, and anxiety/depression, along with a question about global
health (EQ-5D), the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale,
the Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue scale, and the
Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-15) at baseline and
periodically during study.
After completion of study treatment, patients are followed up every 3 months for up to 10
years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Disease-free survival (DFS)
Spearman's Rank Correlation Coefficient will be calculated to test whether there is a relationship between pazopanib hydrochloride trough levels and DFS.
Time from randomization to recurrence, development of second primary cancer, or death from any cause, assessed up to 10 years
No
Leonard Appleman
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2012-00723
NCT01575548
August 2012
Name | Location |
---|---|
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Hurley Medical Center | Flint, Michigan 48503 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Munson Medical Center | Traverse City, Michigan 49684 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Grandview Hospital | Dayton, Ohio 45405 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Hematology Oncology Associates of Illinois-Highland Park | Highland Park, Illinois 60035 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Saint Luke's Hospital | Chesterfield, Missouri 63017 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Providence Centralia Hospital | Centralia, Washington 98531-9027 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Wellmont Holston Valley Hospital and Medical Center | Kingsport, Tennessee 37662 |
City of Hope | Duarte, California 91010 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Northwestern University | Chicago, Illinois 60611 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Columbus CCOP | Columbus, Ohio 43206 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Oregon Health and Science University | Portland, Oregon 97201 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
Provena Saint Mary's Hospital | Kankakee, Illinois 60901 |
North Shore Hematology Oncology | Libertyville, Illinois 60048 |
Good Samaritan Regional Medical Center | Mt. Vernon, Illinois 62864 |
Hematology Oncology Associates of Illinois - Skokie | Skokie, Illinois 60076 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
McFarland Clinic | Ames, Iowa 50010 |
Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Saint Louis-Cape Girardeau CCOP | Saint Louis, Missouri 63141 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Orange Regional Medical Center | Middletown, New York 10940 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Kinston Medical Specialists PA | Kinston, North Carolina 28501 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Natalie W Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Pottstown Memorial Medical Center | Pottstown, Pennsylvania 19464 |
Southwest VA Regional Cancer Center | Norton, Virginia 24273 |
Auburn Regional Medical Center | Auburn, Washington 98002 |
Saint Francis Hospital | Federal Way, Washington 98003 |
Providence - Saint Peter Hospital | Olympia, Washington 98506-5166 |
Good Samaritan Community Hospital | Puyallup, Washington 98372 |
Northwest CCOP | Tacoma, Washington 98405 |
Multicare Health System | Tacoma, Washington 98415 |
Saint Clare Hospital | Tacoma, Washington 98499 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc, Wisconsin 53066-3896 |
Moores University of California San Diego Cancer Center | LA Jolla, California 92093 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Erlanger Medical Center | Chattanooga, Tennessee 37403 |
University of Tennessee - Knoxville | Knoxville, Tennessee 37920 |
Saint Joseph Regional Medical Center | Lewiston, Idaho 83501 |
Spectrum Health Reed City Hospital | Reed City, Michigan 49677 |
The Mark H Zangmeister Center | Columbus, Ohio 43219 |
Southern Ohio Medical Center | Portsmouth, Ohio 45662 |
Cancer Care Associates-Mercy | Oklahoma City, Oklahoma 73120 |
Overlake Hospital Medical Center | Bellevue, Washington 98004 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Franciscan St. Francis Health | Indianapolis, Indiana 46237 |
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |
Illinois Cancer Specialists-Niles | Niles, Illinois 60714 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Saint Louis Cancer and Breast Institute-South City | Saint Louis, Missouri 63109 |
Blue Ridge Medical Specialists PC | Bristol, Tennessee 37620 |
Cancer Care Associates-Norman | Norman, Oklahoma 73071 |
D N Greenwald Center | Mukwonago, Wisconsin 53149 |
Idaho Urologic Institute PA | Meridian, Idaho 83642 |
Wellmont Bristol Regional Medical Center | Bristol, Tennessee 37620 |