Clinical trial NCT00669422: ChemoFx® PRO - A Post-Market Data Collection Study
Official title: ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Uterine Neoplasms
Endometrial Cancer
Vaginal Cancer
Vulvar Cancer
Cervical Cancer
Keywords: 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
Lead sponsor: Precision Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-04-30
Enrollment: 2756
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 3,000 patients from 150 academic and community based physicians in the United States.

Patients have a confirmed solid tumor malignancy and their tissue specimen has been submitted to Precision Therapeutics, Inc. as part of the patient's medical care

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 24-36 Months depending on Disease Status
Secondary outcomes:
measure: Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers.
timeFrame: 24-36 Months depending on Disease Status
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Sherman Oaks
country: United States
facility: Women's Cancer Center of Southern California
state: California
city: Torrance
country: United States
facility: GOA Torrance Memorial
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boca Raton
country: United States
facility: South Florida Center for Gynecologic Oncology
state: Florida
city: Clearwater
country: United States
facility: West Coast Gynecologic Oncology
state: Florida
city: Coconut Creek
country: United States
facility: Florida Center for Gynecologic Oncology
state: Florida
city: Delray Beach
country: United States
facility: Comprehensive Gynecologic Oncology
state: Florida
city: Fort Lauderdale
country: United States
facility: Caruso and Gates MDs PA
state: Florida
city: Fort Myers
country: United States
facility: Florida Gynecologic Oncology
state: Florida
city: Hollywood
country: United States
facility: Gynecologic Oncology Associates
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: South Miami
country: United States
facility: South Miami Gynecologic Oncology Group
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Riverdale
country: United States
facility: Southeastern Gynecologic Oncology, LLC
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Honolulu
country: United States
facility: The Queens' Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Evanston
country: United States
facility: NorthShore Medical Group
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Covington
country: United States
facility: Women's Cancer Center
state: Louisiana
city: Shreveport
country: United States
facility: CHRISTUS Schumpert Health System
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital
state: Maryland
city: Silver Springs
country: United States
facility: Women's Health Specialists
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Gynecologic Oncology of West Michigan
state: Michigan
city: Jackson
country: United States
facility: Mississippi Oncology Associates
state: Mississippi
city: Morristown
country: United States
facility: Atlantic Health Systems
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Gara M Sommers MD
state: New Jersey
city: Voorhees
country: United States
facility: Cooper Health System
state: New Jersey
city: Albany
country: United States
facility: Women's Cancer Care Associates
state: New York
city: Atlantic Beach
country: United States
facility: St. John's Episcopal Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Manhassett
country: United States
facility: North Shore LIJ Health System
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: New York Downtown Hospital
state: New York
city: Asheville
country: United States
facility: Hope: A Women's Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Blumenthal Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Gynecologic Oncology
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Wilmington
country: United States
facility: North Hanover Regional Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: OSU Gynecologic Oncology
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Gynecologic Oncology Group
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina Hospital
state: South Carolina
city: Sioux Falls
country: United States
facility: Sandford USD Health System
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Gynecologic Oncology
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga's Program in Women's Oncology
state: Tennessee
city: Knoxville
country: United States
facility: Thomas W. McDonald MD
state: Tennessee
city: Dallas
country: United States
facility: North Texas Gynecologic Oncology
state: Texas
city: Ft. Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Gynecologic Oncology
state: Texas
city: Annandale
country: United States
facility: North Virigina Pelvic Surgery Associates
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic Gynecologic Oncology
state: Virginia
city: Morgantown
country: United States
facility: Mohammed Ashraf MD
state: West Virginia
city: West Allis
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
Study officials:
References:
citation: 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. doi: 10.3322/canjclin.54.1.8.
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.
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. doi: 10.1006/gyno.2001.6395.
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. doi: 10.3816/ccc.2004.s.007.