Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer

The traditional treatment course for new cases of ovarian, fallopian tube, or peritoneal
cancer is cytoreductive surgery followed by chemotherapy with paclitaxel in combination with
carboplatin. Unfortunately, despite high initial response rates, the majority of patients
recur and subsequent therapy is much less likely to be effective. 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.

Resistance to chemotherapy cannot be predicted by either clinical or histological
examination. Historically, the ex vivo sensitivity and resistance of tumor cells has been
evaluated as a tool for predicting the clinical response of the patient to therapy. In this
study, chemotherapy drugs will be tested using both the Precision Therapeutics' ChemoFx
Assay and the Yale Apoptosis Assay. The assay results will be compared to clinical outcomes
that will be reported at regular intervals. Blood, 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.

This is a one-arm validation trial with a goal of approximately 256 evaluable patients
recruited from multiple sites. Patients will be drawn from the Yale -New Haven Medical
Center and multiple additional sites as needed to meet accrual goals. The patients will be
treated with FDA approved drugs and/or drug combinations based on the medical judgment of
the treating physician. The study is not randomized and the results of the assay will not be
used in the decision process for which agent to select for treatment, but are made available
to the treating physician upon further progression.