Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2756 participants
OBSERVATIONAL
2006-10-31
2012-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
* Patient must be at least 18 years of age
* Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.
Exclusion Criteria
* Patient is not indicated to receive chemotherapy for their disease
18 Years
FEMALE
No
Sponsors
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Precision Therapeutics
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Women's Cancer Center of Southern California
Sherman Oaks, California, United States
GOA Torrance Memorial
Torrance, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
South Florida Center for Gynecologic Oncology
Boca Raton, Florida, United States
West Coast Gynecologic Oncology
Clearwater, Florida, United States
Florida Center for Gynecologic Oncology
Coconut Creek, Florida, United States
Comprehensive Gynecologic Oncology
Delray Beach, Florida, United States
Caruso and Gates MDs PA
Fort Lauderdale, Florida, United States
Florida Gynecologic Oncology
Fort Myers, Florida, United States
Gynecologic Oncology Associates
Hollywood, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
South Miami Gynecologic Oncology Group
South Miami, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Southeastern Gynecologic Oncology, LLC
Riverdale, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
The Queens' Medical Center
Honolulu, Hawaii, United States
Rush University
Chicago, Illinois, United States
NorthShore Medical Group
Evanston, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Women's Cancer Center
Covington, Louisiana, United States
CHRISTUS Schumpert Health System
Shreveport, Louisiana, United States
Sinai Hospital
Baltimore, Maryland, United States
Women's Health Specialists
Silver Springs, Maryland, United States
UMass Memorial Hospital
Worcester, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Gynecologic Oncology of West Michigan
Grand Rapids, Michigan, United States
Mississippi Oncology Associates
Jackson, Mississippi, United States
Atlantic Health Systems
Morristown, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Gara M Sommers MD
Teaneck, New Jersey, United States
Cooper Health System
Voorhees Township, New Jersey, United States
Women's Cancer Care Associates
Albany, New York, United States
St. John's Episcopal Hospital
Atlantic Beach, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore LIJ Health System
Manhassett, New York, United States
Columbia University Medical Center
New York, New York, United States
New York Downtown Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Hope: A Women's Cancer Center
Asheville, North Carolina, United States
Blumenthal Cancer Center
Charlotte, North Carolina, United States
Presbyterian Gynecologic Oncology
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
North Hanover Regional Medical Center
Wilmington, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
OSU Gynecologic Oncology
Columbus, Ohio, United States
Oklahoma Gynecologic Oncology Group
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Medical University of South Carolina Hospital
Charleston, South Carolina, United States
Sandford USD Health System
Sioux Falls, South Dakota, United States
Chattanooga Gynecologic Oncology
Chattanooga, Tennessee, United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, United States
Thomas W. McDonald MD
Knoxville, Tennessee, United States
North Texas Gynecologic Oncology
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
South Texas Gynecologic Oncology
San Antonio, Texas, United States
North Virigina Pelvic Surgery Associates
Annandale, Virginia, United States
Carilion Clinic Gynecologic Oncology
Roanoke, Virginia, United States
Mohammed Ashraf MD
Morgantown, West Virginia, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Countries
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References
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Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8.
Ness RB, Wisniewski SR, Eng H, Christopherson W. Cell viability assay for drug testing in ovarian cancer: in vitro kill versus clinical response. Anticancer Res. 2002 Mar-Apr;22(2B):1145-9.
O'Meara AT, Sevin BU. Predictive value of the ATP chemosensitivity assay in epithelial ovarian cancer. Gynecol Oncol. 2001 Nov;83(2):334-42. doi: 10.1006/gyno.2001.6395.
McLeod HL, King CR, Marsh S. Application of pharmacogenomics in the individualization of chemotherapy for gastrointestinal malignancies. Clin Colorectal Cancer. 2004 Jun;4 Suppl 1:S43-7. doi: 10.3816/ccc.2004.s.007.
Other Identifiers
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PT-206 ChemoFx® PRO Study
Identifier Type: -
Identifier Source: org_study_id