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


N/A
18 Years
N/A
Not Enrolling
Female
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
randomized.


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
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 pathology shows benign pathology for sample submitted

- Patient is not indicated to receive chemotherapy for their disease

Type of Study:

Observational

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:

No

Authority:

United States: Institutional Review Board

Study ID:

PT-206 ChemoFx® PRO Study

NCT ID:

NCT00669422

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Hartford HospitalHartford, Connecticut  06102-5037
Sarasota Memorial HospitalSarasota, Florida  34239
Montefiore Medical CenterBronx, New York  10467-2490
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Oregon Health & Science UniversityPortland, Oregon  97201
Duke University Medical CenterDurham, North Carolina  27710
University of California San FranciscoSan Francisco, California  941104206
Henry Ford Health SystemDetroit, Michigan  48202
Yale UniversityNew Haven, Connecticut  06520
Allegheny-Singer Research InstitutePittsburgh, Pennsylvania  15212
Blumenthal Cancer CenterCharlotte, North Carolina  28203
The Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Sinai HospitalBaltimore, Maryland  21215
Florida Gynecologic OncologyFort Myers, Florida  33901
Indiana UniversityIndianapolis, Indiana  46202
Karmanos Cancer InstituteDetroit, Michigan  48201
Gynecologic Oncology AssociatesPembroke Pines, Florida  33028
Memorial Health University Medical CenterSavannah, Georgia  31404
Jersey Shore University Medical CenterNeptune, New Jersey  07754
Presbyterian Gynecologic OncologyCharlotte, North Carolina  28204
Gynecologic Oncology of West MichiganGrand Rapids, Michigan  49546
Women's Cancer Care AssociatesAlbany, New York  12208
Chattanooga's Program in Women's OncologyChattanooga, Tennessee  37403
University of CincinnatiCincinnati, Ohio  45267-0502
Columbia University Medical CenterNew York, New York  10032
Cooper Health SystemVoorhees, New Jersey  08043
University of South AlabamaMobile, Alabama  36693
Southeastern Gynecologic Oncology, LLCAtlanta, Georgia  30342
New York Downtown HospitalNew York, New York  10038
Rush UniversityChicago, Illinois  60612
Women & Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Women's Cancer Center of Southern CaliforniaSherman Oaks, California  91403
GOA Torrance MemorialTorrance, California  91403
South Florida Center for Gynecologic OncologyBoca Raton, Florida  33487
West Coast Gynecologic OncologyClearwater, Florida  33756
Florida Center for Gynecologic OncologyCoconut Creek, Florida  33073
Comprehensive Gynecologic OncologyDelray Beach, Florida  33444
Caruso and Gates MDs PAFort Lauderdale, Florida  33308
South Miami Gynecologic Oncology GroupSouth Miami, Florida  33143
The Queens' Medical CenterHonolulu, Hawaii  96813
NorthShore Medical GroupEvanston, Illinois  60201
Women's Cancer CenterCovington, Louisiana  70433
CHRISTUS Schumpert Health SystemShreveport, Louisiana  71101
Women's Health SpecialistsSilver Springs, Maryland  20852
UMass Memorial HospitalWorcester, Massachusetts  01605
Mississippi Oncology AssociatesJackson, Mississippi  39216
Atlantic Health SystemsMorristown, New Jersey  07962
Gara M Sommers MDTeaneck, New Jersey  07066
St. John's Episcopal HospitalAtlantic Beach, New York  11509
North Shore LIJ Health SystemManhassett, New York  11030
Hope: A Women's Cancer CenterAsheville, North Carolina  28806
North Hanover Regional Medical CenterWilmington, North Carolina  28402
OSU Gynecologic OncologyColumbus, Ohio  43026
Oklahoma Gynecologic Oncology GroupOklahoma City, Oklahoma  73112
Medical University of South Carolina HospitalCharleston, South Carolina  29403
Sandford USD Health SystemSioux Falls, South Dakota  57105
Chattanooga Gynecologic OncologyChattanooga, Tennessee  37403
Thomas W. McDonald MDKnoxville, Tennessee  37922
North Texas Gynecologic OncologyDallas, Texas  75251
South Texas Gynecologic OncologySan Antonio, Texas  78258
North Virigina Pelvic Surgery AssociatesAnnandale, Virginia  22003
Carilion Clinic Gynecologic OncologyRoanoke, Virginia  24016
Mohammed Ashraf MDMorgantown, West Virginia  26505
Aurora West Allis Medical CenterWest Allis, Wisconsin  53227