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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

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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



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