Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)
*****UPDATE***** On October 30th, 2007 GPC Biotech announced topline overall survival
results for the Phase III trial in hormone refractory prostate cancer-Satraplatin and
Prednisone Against Refractory Cancer (SPARC) trial.
The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a
second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The
companies reported that the trial did not achieve the endpoint of overall survival (p=0.80,
stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared
to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The
companies are currently conducting pre-specified subset analyses.
Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based
drugs have been clinically proven to be one of the most effective classes of anticancer
therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given
orally.
Inclusion Criteria:
- Metastatic(Stage D2)prostate cancer
- Progression after unlimited prior cytotoxic chemotherapy regimens
- ECOG Performance status equal/less than 2
- Surgical or medical castration
- Adequate bone marrow, liver, and renal function
- Informed consent
- Patients treated with bisphosphonates prior to entry are eligible and should
continue bisphosphonates therapy while on this trial
Exclusion Criteria:
- Serious concurrent uncontrolled medical disorder
- Malignant disease requiring on-going therapy
- Prior significant RT/radionuclide therapy
- Major GI surgery or GI disease affecting absorption
- Disease where corticosteroids are contraindicated
- Brain metastases
- Poorly-controlled or uncontrolled insulin-dependent diabetes
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The SPERA trial is designed to provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited prior cytotoxic chemotherapy regimens for metastatic disease.
Outcome Time Frame:
Patient evaluation by MD at baseline to determine eligibility.
Safety Issue:
Yes
Principal Investigator
Philippe Pultar, MD
Investigator Role:
Study Director
Investigator Affiliation:
GPC Biotech Inc.
Authority:
United States: Food and Drug Administration
Study ID:
SAT3-06-04
NCT ID:
NCT00450970
Start Date:
February 2007
Completion Date:
December 2009
Related Keywords:
- Prostate Cancer
- Hormone Refractory Prostate Cancer (HRPC)
- Hormone Refractory Prostate Cancer
- Unlimited Prior Cytotoxic Chemotherapy Regimens
- Prostatic Neoplasms
Name | Location |
|---|---|
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
| Harrington Cancer Center | Amarillo, Texas 79106 |
| Providence Alaska Medical Center | Anchorage, Alaska 99508 |
| Virginia Oncology Associates | Newport News, Virginia 23606 |
| Trinity Cancer Care Center | Minot, North Dakota 58701 |
| Rocky Mountain Cancer Center | Denver, Colorado 80218 |
| Ocala Oncology Center | Ocala, Florida 34474 |
| Green Bay Oncology, Ltd. | Green Bay, Wisconsin 54307-3453 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
| Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
| Pacific Shores Medical Group | Long Beach, California 90813 |
| Lakeland Regional Medical Center | Lakeland, Florida 33804 |
| Gaston Hematology and Oncology | Gastonia, North Carolina 28054 |
| Genesis Cancer Center | Hot Springs, Arkansas 71913 |
| Center for Hematology-Oncology | Boca Raton, Florida 33486 |
| Medical Oncology Care Associates | Orange, California 92668 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| Associates in Oncology/Hematology | Rockville, Maryland 20850 |
| Center for Oncology Research and Treatment | Dallas, Texas 75230 |
| Northern Utah Associates | Ogden, Utah 84403 |
| Stockton Hematology Oncology Medical Group | Stockton, California 95204 |
| Lahey Clinic | Burlington, Massachusetts 01805 |
| University of Chicago | Chicago, Illinois 60637 |
| Urology Centers Of Alabama | Homewood,, Alabama 35205 |
| Texas Oncology | Dallas, Texas |
| Pacific Hematology Oncology Associates | San Francisco, California 94115 |
| Santa Barbara Hematology Oncology Medical Group | Lompoc, California 93438 |
| North Valley Hematology/Oncology Medical Group | Northridge, California 91328 |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids, Michigan 49546 |
| Allison Cancer Center | Midland, Texas 79701 |
| Peninsula Cancer Institute | Newport News, Virginia 23601 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| Hematology Oncology Associates of Northern New Jersey | Morristown, New Jersey 07960 |
| The Jones Clinic | Germantown, Tennessee 38138 |
| Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
| The Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
| St. Johns Mercy Medical Center | St. Louis, Missouri 63141 |
| Birmingham Hematology and Oncology | Birmingham, Alabama 35235 |
| Texas Cancer Center | Abilene, Texas 79606 |
| Ephrata Cancer Center | Ephrata, Pennsylvania 17522 |
| East Valley Hematology Oncology Medical Group | Burbank, California 91505 |
| Dallas Oncology Consultants, PA | Dallas, Texas 75237 |
| The Center for Cancer Care & Research | St. Louis, Missouri 63141 |
| Northwest Cancer Specialists, PC | Vancouver, Washington 98684 |
| Cedar Valley Medical Specialists | Waterloo, Iowa 50702 |
| Cancer Specialists of Oklahoma | Oklahoma City, Oklahoma 73112 |
| Oncology Associates of Bridgeport | Trumball, Connecticut 06611 |
| Kalamazoo Hematology and Oncology | Kalamazoo, Michigan 49048 |
| Gainesville Hematology Oncology Associates | Gainesville, Florida 32605 |
| Coastal Bend Cancer Center | Corpus Christi, Texas 78404 |
| McLeod Cancer and Blood Center | Johnson City, Tennessee 37604 |
| Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
| Jackson Oncology Associates | Jackson, Mississippi 39202 |
| Connecticut Oncology & Hematology, LLP | Torrington, Connecticut 06790 |
| Ohio Cancer Specialists | Mansfield, Ohio 44907 |
| Lone Star Oncology Consultants | Austin, Texas 78759 |
| Richmond University Medical Center | Staten Island, New York 10310-1699 |
| Pacific Cancer Medical Center, Inc | Anaheim, California 92801 |
| Lancaster Cancer Center, Ltd. | Lancaster, Pennsylvania 17601 |
| The Christ Hospital | Cincinnati, Ohio 45219 |
| Mid-Ohio Oncology/Hematology | Columbus, Ohio 43219 |
| Mcfarland Clinic Pc | Ames, Iowa 50010 |
| Carraway Cancer Clinic | Birmingham, Alabama 35234 |
| Clopton Clinic | Jonesboro, Arkansas 72401 |
| Michael Harris MD | Mission Viejo, California 92691 |
| Newport Cancer Care Medical Assoc., Inc. | Newport Beach, California 92663 |
| Desert Cancer Center | Rancho Mirage, California 92270 |
| Santa Barbara Hemotology | Santa Barbara, California 93105 |
| Sierra Nevada Oncology | Truckee, California 96161 |
| Medical Specialists of Fairfield, LLC | Fairfield, Connecticut 06284 |
| Davis, Posteraro, and Wasser, MDs, LLP | Manchester, Connecticut 06040 |
| Whittigham Cancer Center at Norwalk Hospital | Norwalk, Connecticut 06856 |
| Hematology Oncology | Stamford, Connecticut 06902 |
| Florida Cancer Specalists | Bradenton, Florida 34209 |
| Florida Cancer Care Specialists-Fort Myers Summerlin Office | Fort Myers, Florida 33908 |
| ICON | Jacksonville, Florida 32256 |
| MIMA Century Research Assoc. | Melbourne, Florida 32901 |
| Marc I. Saltzman | Miami, Florida 33138 |
| Mid-Florida Hematology & Oncology Centers | Orange City, Florida 32763 |
| Sacred Heart Hospital Cancer Research | Pensacola, Florida 32504 |
| Notheast Georgia Cancer Care, LLC | Athens, Georgia 30607 |
| Medical Oncology Assoc. of Augusta, PC | Augusta, Georgia 30901 |
| GA Urology | Decatur, Georgia 30033 |
| Suburban Hematology-Oncology Assoc., PC | Lawrenceville, Georgia 30045 |
| Medical & Surgical Spealists, LLC | Galesburg, Illinois 61401 |
| Urology Associates, S.C. | Mattoon, Illinois 61938 |
| Mid-Illinois Hematology and Oncology Assoc., LTD | Normal, Illinois 61761 |
| Oncology Hematology Associates of Central IL, PC | Peoria, Illinois 61615 |
| Fort Wayne Medical Oncology Hematology, Inc. | Fort Wayne, Indiana 46815 |
| Mahendra M. Shah, MD, FACP | Hammond, Indiana 46320 |
| Iowa Blood and Cancer Care, PLC | Cedar Rapids, Iowa 52402 |
| Heartland Oncology & Hematology, LLP | Council Bluffs, Iowa 51503 |
| Drs.Caroll, Sheth and Raghavan | Louisville, Kentucky 40215 |
| The Center for Clinical Research | Hagerstown, Maryland 21740 |
| NW MS Hem/Onc (Tupelo) | Tupelo, Mississippi 38801 |
| Columbia Comprehensive Cancer Care Center | Columbia, Missouri 65201 |
| The Billings Clinic | Billings, Montana 59101 |
| Saint Francis Memoiral Hospital | Grand Island, Nebraska 68803 |
| Nebraska Hematology-Oncology,PC | Lincoln, Nebraska 68506 |
| Cancer Care at St. Claire's | Denville, New Jersey 07834 |
| Northern Valley Medical | Westwood, New Jersey 07675 |
| Hematology Oncology Assoc. of W. Suffolk, PC | Bay Shore, New York 11706 |
| North Shore Hematology Oncology Assoc. | E. Setauket, New York 11733 |
| Cancer Center of North Carolina | Raleigh, North Carolina 27614 |
| MeritCare Clinical Research | Fargo, North Dakota 58122 |
| Tricounty Hem/Onc Associates | Canton, Ohio 44718 |
| Hematology-Oncology Consultants, Inc | Columbus, Ohio 43235 |
| Greater Philadelphia Cancer Center | Philadelphia, Pennsylvania 19114 |
| Carolina Health Care | Florence, South Carolina 29501 |
| Mid-South Cancer Center | Germantown, Tennessee 38138 |
| Mid-South Cancer Center, PC | Germantown, Tennessee 38138 |
| Kingsport Hematology Oncology | Kingsport, Tennessee 37660 |
| Boston Baskin Cancer Group D/B/A/ UTCI | Memphis, Tennessee 38104 |
| Texas Oncology Cancer Center, PA | Austin, Texas 78731 |
| Mitchell Medical Clinic | Daingerfield, Texas 75638 |
| Clinical Oncology & Hematology, LLP | Dallas, Texas 75235 |
| Sacred Heart Medical Center - Providence Cancer Care Center | Spokane, Washington 99204 |
