ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes
The traditional treatment course for new cases of many cancers is cytoreductive surgery
followed by chemotherapy. Unfortunately, despite high initial response rates to treatment,
the majority of patients recur. The use of ineffective chemotherapy can result in
unnecessary toxicity and costs, delay of more effective treatment, and the potential for the
development of cross-resistance to additional drugs. The ability to individualize therapy by
providing the treating physician with ex vivo response information on a panel of drugs
should aid in the selection of effective therapy for individual patients, thus resulting in
improved outcomes.
ChemoFx® is a drug response marker that quantifies an individual cancer patient's probable
tumor response to various chemotherapeutic and biologic agents—providing both sensitivity
and resistance information. In a retrospective study, it was demonstrated that patients
treated with a regimen that the ChemoFx® test said the patients' cells would be sensitive
to, corresponded to a 3 times longer progression free interval.
In the PT-206 ChemoFx PRO® study, patients will be followed through treatment, until the
patient progresses or a significant change in chemotherapy occurs. This data will be
collected and analyzed to identify potential patient cohorts for the development of
hypotheses for future sub-study analysis. Also, tumor pathology slides and excess tumor
cells (if available) will be used to characterize common polymorphisms in drug metabolizing
enzymes as well as other molecular markers potentially associated with tumor response.
The PT-206 ChemoFx PRO® Study seeks to enroll an estimated 3,000 patients from 150 academic
and community-based physicians in the U.S. The patients will be treated with drugs and/or
drug combinations based on the medical judgment of the treating physician. This study is not
randomized.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
To collect physician reported outcomes after the first chemotherapy utilized following the receipt of a final report from ChemoFx® in solid tumor malignancies for the generation of hypotheses for further sub-study.
24-36 Months depending on Disease Status
No
United States: Institutional Review Board
PT-206 ChemoFx® PRO Study
NCT00669422
October 2006
October 2012
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Sarasota Memorial Hospital | Sarasota, Florida 34239 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of California San Francisco | San Francisco, California 941104206 |
Henry Ford Health System | Detroit, Michigan 48202 |
Yale University | New Haven, Connecticut 06520 |
Allegheny-Singer Research Institute | Pittsburgh, Pennsylvania 15212 |
Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
The Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Sinai Hospital | Baltimore, Maryland 21215 |
Florida Gynecologic Oncology | Fort Myers, Florida 33901 |
Indiana University | Indianapolis, Indiana 46202 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Gynecologic Oncology Associates | Pembroke Pines, Florida 33028 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Jersey Shore University Medical Center | Neptune, New Jersey 07754 |
Presbyterian Gynecologic Oncology | Charlotte, North Carolina 28204 |
Gynecologic Oncology of West Michigan | Grand Rapids, Michigan 49546 |
Women's Cancer Care Associates | Albany, New York 12208 |
Chattanooga's Program in Women's Oncology | Chattanooga, Tennessee 37403 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Columbia University Medical Center | New York, New York 10032 |
Cooper Health System | Voorhees, New Jersey 08043 |
University of South Alabama | Mobile, Alabama 36693 |
Southeastern Gynecologic Oncology, LLC | Atlanta, Georgia 30342 |
New York Downtown Hospital | New York, New York 10038 |
Rush University | Chicago, Illinois 60612 |
Women & Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Women's Cancer Center of Southern California | Sherman Oaks, California 91403 |
GOA Torrance Memorial | Torrance, California 91403 |
South Florida Center for Gynecologic Oncology | Boca Raton, Florida 33487 |
West Coast Gynecologic Oncology | Clearwater, Florida 33756 |
Florida Center for Gynecologic Oncology | Coconut Creek, Florida 33073 |
Comprehensive Gynecologic Oncology | Delray Beach, Florida 33444 |
Caruso and Gates MDs PA | Fort Lauderdale, Florida 33308 |
South Miami Gynecologic Oncology Group | South Miami, Florida 33143 |
The Queens' Medical Center | Honolulu, Hawaii 96813 |
NorthShore Medical Group | Evanston, Illinois 60201 |
Women's Cancer Center | Covington, Louisiana 70433 |
CHRISTUS Schumpert Health System | Shreveport, Louisiana 71101 |
Women's Health Specialists | Silver Springs, Maryland 20852 |
UMass Memorial Hospital | Worcester, Massachusetts 01605 |
Mississippi Oncology Associates | Jackson, Mississippi 39216 |
Atlantic Health Systems | Morristown, New Jersey 07962 |
Gara M Sommers MD | Teaneck, New Jersey 07066 |
St. John's Episcopal Hospital | Atlantic Beach, New York 11509 |
North Shore LIJ Health System | Manhassett, New York 11030 |
Hope: A Women's Cancer Center | Asheville, North Carolina 28806 |
North Hanover Regional Medical Center | Wilmington, North Carolina 28402 |
OSU Gynecologic Oncology | Columbus, Ohio 43026 |
Oklahoma Gynecologic Oncology Group | Oklahoma City, Oklahoma 73112 |
Medical University of South Carolina Hospital | Charleston, South Carolina 29403 |
Sandford USD Health System | Sioux Falls, South Dakota 57105 |
Chattanooga Gynecologic Oncology | Chattanooga, Tennessee 37403 |
Thomas W. McDonald MD | Knoxville, Tennessee 37922 |
North Texas Gynecologic Oncology | Dallas, Texas 75251 |
South Texas Gynecologic Oncology | San Antonio, Texas 78258 |
North Virigina Pelvic Surgery Associates | Annandale, Virginia 22003 |
Carilion Clinic Gynecologic Oncology | Roanoke, Virginia 24016 |
Mohammed Ashraf MD | Morgantown, West Virginia 26505 |
Aurora West Allis Medical Center | West Allis, Wisconsin 53227 |