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NCT00669422 Clinical Trial

ChemoFx® PRO - A Post-Market Data Collection Study

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00669422
Other study ID # PT-206 ChemoFx® PRO Study
Secondary ID
Status Terminated
Phase N/A
First received April 25, 2008
Last updated October 4, 2012
Start date October 2006
Est. completion date October 2012

Study information
Verified date October 2012
Source Precision Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2756
Est. completion date October 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Women's Cancer Care Associates Albany New York
United States North Virigina Pelvic Surgery Associates Annandale Virginia
United States Hope: A Women's Cancer Center Asheville North Carolina
United States St. John's Episcopal Hospital Atlantic Beach New York
United States Sinai Hospital Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States South Florida Center for Gynecologic Oncology Boca Raton Florida
United States Montefiore Medical Center Bronx New York
United States Roswell Park Cancer Institute Buffalo New York
United States Medical University of South Carolina Hospital Charleston South Carolina
United States Blumenthal Cancer Center Charlotte North Carolina
United States Presbyterian Gynecologic Oncology Charlotte North Carolina
United States Chattanooga Gynecologic Oncology Chattanooga Tennessee
United States Chattanooga's Program in Women's Oncology Chattanooga Tennessee
United States Rush University Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States West Coast Gynecologic Oncology Clearwater Florida
United States Florida Center for Gynecologic Oncology Coconut Creek Florida
United States OSU Gynecologic Oncology Columbus Ohio
United States Women's Cancer Center Covington Louisiana
United States North Texas Gynecologic Oncology Dallas Texas
United States Comprehensive Gynecologic Oncology Delray Beach Florida
United States Henry Ford Health System Detroit Michigan
United States Karmanos Cancer Institute Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States NorthShore Medical Group Evanston Illinois
United States Caruso and Gates MDs PA Fort Lauderdale Florida
United States Florida Gynecologic Oncology Fort Myers Florida
United States Brooke Army Medical Center Ft. Sam Houston Texas
United States Gynecologic Oncology of West Michigan Grand Rapids Michigan
United States Hartford Hospital Hartford Connecticut
United States Gynecologic Oncology Associates Hollywood Florida
United States The Queens' Medical Center Honolulu Hawaii
United States Indiana University Indianapolis Indiana
United States Mississippi Oncology Associates Jackson Mississippi
United States Thomas W. McDonald MD Knoxville Tennessee
United States North Shore LIJ Health System Manhassett New York
United States University of South Alabama Mobile Alabama
United States Mohammed Ashraf MD Morgantown West Virginia
United States Atlantic Health Systems Morristown New Jersey
United States Jersey Shore University Medical Center Neptune New Jersey
United States Yale University New Haven Connecticut
United States Columbia University Medical Center New York New York
United States New York Downtown Hospital New York New York
United States Oklahoma Gynecologic Oncology Group Oklahoma City Oklahoma
United States Allegheny-Singer Research Institute Pittsburgh Pennsylvania
United States The Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Women & Infants Hospital of Rhode Island Providence Rhode Island
United States Southeastern Gynecologic Oncology, LLC Riverdale Georgia
United States Carilion Clinic Gynecologic Oncology Roanoke Virginia
United States South Texas Gynecologic Oncology San Antonio Texas
United States University of California San Francisco San Francisco California
United States Sarasota Memorial Hospital Sarasota Florida
United States Memorial Health University Medical Center Savannah Georgia
United States Women's Cancer Center of Southern California Sherman Oaks California
United States CHRISTUS Schumpert Health System Shreveport Louisiana
United States Women's Health Specialists Silver Springs Maryland
United States Sandford USD Health System Sioux Falls South Dakota
United States South Miami Gynecologic Oncology Group South Miami Florida
United States Gara M Sommers MD Teaneck New Jersey
United States GOA Torrance Memorial Torrance California
United States Cooper Health System Voorhees New Jersey
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Palm Beach Cancer Institute West Palm Beach Florida
United States North Hanover Regional Medical Center Wilmington North Carolina
United States UMass Memorial Hospital Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Precision Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

O'Meara AT, Sevin BU. Predictive value of the ATP chemosensitivity assay in epithelial ovarian cancer. Gynecol Oncol. 2001 Nov;83(2):334-42. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 24-36 Months depending on Disease Status No
Secondary Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers. 24-36 Months depending on Disease Status No
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