Know Cancer

forgot password

ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes

18 Years
Not Enrolling
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Uterine Neoplasms, Endometrial Cancer, Vaginal Cancer, Vulvar Cancer, Cervical Cancer

Thank you

Trial Information

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

Inclusion Criteria:

- Patient has been diagnosed with a solid tumor malignancy and their physician has
received a final report for ChemoFx® after August 1, 2006

- Chemotherapy must be clinically indicated for treatment of the patient's qualifying

- 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 pathology shows benign pathology for sample submitted

- Patient is not indicated to receive chemotherapy for their disease

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

24-36 Months depending on Disease Status

Safety Issue:



United States: Institutional Review Board

Study ID:

PT-206 ChemoFx® PRO Study



Start Date:

October 2006

Completion Date:

October 2012

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Uterine Neoplasms
  • Endometrial Cancer
  • Vaginal Cancer
  • Vulvar Cancer
  • Cervical Cancer
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Uterine Neoplasms
  • Vulvar Cancer
  • Endometrial Cancer
  • Cervical Cancer
  • Assay
  • Chemotherapy
  • Recurrent
  • Refractory
  • Persistent
  • Chemoresponse
  • Sensitivity
  • Precision Therapeutics
  • ChemoFx
  • Neoplasms
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Uterine Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma



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