ChemoFx® PRO - A Post-Market Data Collection Study
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|ClinicalTrials.gov Identifier: NCT00669422|
Recruitment Status : Terminated
First Posted : April 30, 2008
Last Update Posted : October 5, 2012
|Condition or disease|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Uterine Neoplasms Endometrial Cancer Vaginal Cancer Vulvar Cancer Cervical Cancer|
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.
|Study Type :||Observational|
|Actual Enrollment :||2756 participants|
|Official Title:||ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes|
|Study Start Date :||October 2006|
|Actual Study Completion Date :||October 2012|
- 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. [ Time Frame: 24-36 Months depending on Disease Status ]
- Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers. [ Time Frame: 24-36 Months depending on Disease Status ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669422
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