A Non-Interventional Prospective Study of the Correlation of the Precision Therapeutics, Inc. Chemoresponse Assay With Progression-Free Survival in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer.
The traditional treatment course for new cases of ovarian, fallopian tube, or peritoneal
cancer is cytoreductive surgery followed by chemotherapy with paclitaxel in combination with
carboplatin. Unfortunately, despite high initial response rates, the majority of patients
recur and subsequent therapy is much less likely to be effective. 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.
Resistance to chemotherapy cannot be predicted by either clinical or histological
examination. Historically, the ex vivo sensitivity and resistance of tumor cells has been
evaluated as a tool for predicting the clinical response of the patient to therapy. In this
study, chemotherapy drugs will be tested using both the Precision Therapeutics' ChemoFx
Assay and the Yale Apoptosis Assay. The assay results will be compared to clinical outcomes
that will be reported at regular intervals. Blood, 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.
This is a one-arm validation trial with a goal of approximately 256 evaluable patients
recruited from multiple sites. Patients will be drawn from the Yale -New Haven Medical
Center and multiple additional sites as needed to meet accrual goals. The patients will be
treated with FDA approved drugs and/or drug combinations based on the medical judgment of
the treating physician. The study is not randomized and the results of the assay will not be
used in the decision process for which agent to select for treatment, but are made available
to the treating physician upon further progression.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Progression Free Survival
1. Every Treatment Cycle 2. Every 3 months for the first 2 years post treatment 3. Every 6 months for the next 3 years post treatment 4. Annually thereafter.
No
Thomas J Rutherford, MD
Principal Investigator
Yale University
United States: Institutional Review Board
PT-301
NCT00288275
July 2004
October 2012
Name | Location |
---|---|
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
St. Elizabeth Medical Center | Edgewood, Kentucky 41017 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Saint Louis University | St. Louis, Missouri 63104 |
Cleveland Clinic | Cleveland, Ohio 44195 |
Washington University | St. Louis, Missouri 63110 |
Kaiser Permanente | Sacramento, California |
The Methodist Hospital | Houston, Texas 77030 |
Florida Gynecologic Oncology | Fort Myers, Florida 33901 |
University of Wisconsin, Madison | Madison, Wisconsin 53792 |
Ut Southwestern Medical Center | Dallas, Texas 75390 |
Saint Barnabas Medical Center | Livingston, New Jersey 07039 |
University of California | San Francisco, California 94108 |
University of Virginia Health System | Charlottesville, Virginia 22903 |
Women's Cancer Associates | Saint Petersburg, Florida 33701 |
Schwartz Gynecologic Oncology, PLLC | Babylon, New York 11702 |
Legacy Health System | Portland, Oregon 97210 |
Yale University Medical Center | New Haven, Connecticut 06520 |
St. Vincents Medical Center | Jacksonville, Florida 32204 |
The Florida Hospital | Orlando, Florida 32804 |
Atlanta Medical Center | Atlanta, Georgia 30312 |
Southeastern Gynecologic Oncology Riverdale | Riverdale, Georgia 30274 |
Rush University | Chicago, Illinois 60612 |
Northwestern University/Prentice Women's Hospital | Chicago, Illinois 60611 |
The Cooper Health System | Camden, New Jersey 08103 |
University of Cincinnati Medical Center Barrett Cancer Center | Cincinnati, Ohio 45219 |
University Hospital Case Medical Center | Cleveland, Ohio 44106 |
University of Toledo Medical Center | Toledo, Ohio 43614 |
UPMC Cancer Center at Magee Womens Hospital | Pittsburgh, Pennsylvania 15213 |
Lankenau Hospital, Mainline Health System | Wynnwood, Pennsylvania 19096 |
Women & Infants Hospital | Providence, Rhode Island 02905-2499 |
ACORN - The West Clinic | Memphis, Tennessee 38138 |