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

Stopped early

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

In brief

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.

Key facts

Study ID

NCT00288275

Run by

Precision Therapeutics

People needed

256

Starts

2004-07-01

Expected to finish

2012-10-01

Last updated by the study team

2012-10-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California — Irvine, California, United States
• Kaiser Permanente — Los Angeles, California, United States
• Yale University Medical Center — New Haven, Connecticut, United States
• Florida Gynecologic Oncology — Fort Myers, Florida, United States
• St. Vincents Medical Center — Jacksonville, Florida, United States
• The Florida Hospital — Orlando, Florida, United States
• Women's Cancer Associates — St. Petersburg, Florida, United States
• Atlanta Medical Center — Atlanta, Georgia, United States
• Southeastern Gynecologic Oncology Riverdale — Riverdale, Georgia, United States
• Northwestern University/Prentice Women's Hospital — Chicago, Illinois, United States
• Rush University — Chicago, Illinois, United States
• St. Vincent Indianapolis Hospital — Indianapolis, Indiana, United States
• St. Elizabeth Medical Center — Edgewood, Kentucky, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Saint Louis University — St Louis, Missouri, United States
• The Cooper Health System — Camden, New Jersey, United States
• Saint Barnabas Medical Center — West Orange, New Jersey, United States
• Schwartz Gynecologic Oncology, PLLC — Brightwaters, New York, United States
• University of Cincinnati Medical Center Barrett Cancer Center — Cincinnati, Ohio, United States
• University Hospital Case Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Toledo Medical Center — Toledo, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Legacy Health System — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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