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

Brief Title

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

Official Title

A Non-Interventional Prospective Study of the Correlation of the Precision Therapeutics, Inc. Chemoresponse Assay With Progression-Free Survival in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer.

Brief Summary

      Chemoresponse assays (lab test) measure the effect that chemotherapy treatment has on a
      patient's cancer cells in the lab. This test has shown success in a retrospective study in
      predicting how an individual patient's tumor will respond to a given chemotherapy and how
      treatment utilizing an agent that the test said that a patient's cells would be sensitive too
      corresponds to a longer progression free interval. This study will determine the ability of
      two tests used to predict the success of chemotherapy in recurrent, persistent, or refractory
      cancer of the ovaries, fallopian tube(s) or peritoneum by measuring how long patients live
      without progression.

Detailed Description

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.

Study Type

Observational

Primary Outcome

Progression Free Survival

Secondary Outcome

 Tumor Response

Condition

Ovarian Cancer

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

July 2004

Completion Date

October 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Patient has been diagnosed with persistent, refractory, or recurrent epithelial
             ovarian, peritoneal, or fallopian tube carcinoma.

          -  Patient must have documented disease defined by physical exam, clinically significant
             increases in CA-125 (as defined by protocol), CT, MRI scan, PET, x-ray or ultrasound
             for whom cytoreduction, excisional biopsy, incisional biopsy, or paracentesis is
             medically indicated, or in the alternative, have agreed to a core biopsy of the
             primary site, a secondary metastatic site, or a paracentesis or thoracentesis for
             fluid collection.

          -  Patient has disease of one of the following histologic epithelial cell types: serous
             adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated
             carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not
             otherwise specified (N.O.S.). Cytologic confirmation of diagnosis is acceptable for
             patients treated with neoadjuvant therapy who have not had a surgical procedure for a
             histologic confirmation.

          -  Patient has only received one or two prior chemotherapy regimens for their ovarian,
             peritoneal, or fallopian tube carcinoma. Multiple previous regimens of
             Taxol/Carboplatin will be counted as 1 prior chemotherapy regimen (e.g., A patient who
             receives first line Taxol/Carboplatin, then recurs, then receives Taxol/Carboplatin
             will be considered to have had only 1 prior regimen.)

          -  Patient must have completed prior chemotherapy regimens at least 3 weeks prior to
             tissue extraction.

          -  Patient must have an estimated life expectancy of greater than six months, as
             determined by the investigator.

          -  Patient requires chemotherapy and the investigator plans to administer one of the
             regimens of interest as deemed by her physician.

          -  Patient must be a female and at least 18 years of age. Ovarian cancer is a disease
             that occurs only in women and is exceedingly rare in females under the age of 18.

          -  Patient must have an ECOG Performance Status of 0, 1, or 2.

          -  Tumor tissue or ascitic fluid must be available for the assays. Ascites or Pleural
             alone may be collected and submitted as the sample tissue, but the patient must also
             have measurable disease as demonstrated by a CA-125 level 2X ULN or measurable lesions
             on imaging to be eligible.

          -  Patient must have signed an approved consent form.

        Exclusion Criteria:

          -  Patient has ovarian stromal, mixed mullerian, or germ cell tumors

          -  Patient has borderline carcinoma (uncertain malignant potential)

          -  Pregnant or lactating patients

          -  Patients of childbearing potential not employing adequate contraception.

          -  Patients who are at risk of failure of compliance to the visit schedules and
             procedures.

          -  The investigator plans to use an assay to select the chemotherapy drug regimen. The
             investigator may submit the patient's tissue for testing with other assays, but may
             not use the results of those assays to select the chemotherapy regimen for the patient
             for this trial.

          -  Patients with synchronous primary endometrial cancer or a past history of primary
             endometrial cancer are excluded unless all of the following conditions are met: Stage
             not greater than I-B, Less than 3mm invasion without vascular or lymphatic invasion,
             NO poorly differentiated subtype, including papillary serous, clear cell, or othe FIGO
             Grade 3 lesion.

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas J Rutherford, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00288275

Organization ID

PT-301

Responsible Party

Sponsor

Study Sponsor

Precision Therapeutics

Study Sponsor

Thomas J Rutherford, MD, Principal Investigator, Yale University

Verification Date

October 2012