Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer
NCT ID: NCT00288275
Last Updated: 2012-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
256 participants
OBSERVATIONAL
2004-07-31
2012-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Precision Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas J Rutherford, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Hong Ma, MD
Role: STUDY_DIRECTOR
Precision Therapeutics, Inc.
Locations
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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
Abington Memorial Hospital
Abington, Pennsylvania, United States
UPMC Cancer Center at Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Lankenau Hospital, Mainline Health System
Wynnwood, Pennsylvania, United States
Women & Infants Hospital
Providence, Rhode Island, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
ACORN - The West Clinic
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University of Wisconsin, Madison
Madison, Wisconsin, United States
Countries
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References
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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.
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.
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.
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.
Kaplan EL, Meier P. Nonparametric estimation of incomplete observations. JASA 1958;43:457-481.
Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 5074.
Other Identifiers
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PT-301
Identifier Type: -
Identifier Source: org_study_id
NCT00301717
Identifier Type: -
Identifier Source: nct_alias