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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 1. Every Treatment Cycle 2. Every 3 months for the first 2 years post treatment 3. Every 6 months for the next 3 years post treatment 4. Annually thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | 1. Every treatment cycle 2. Every 3 months for the first 2 years post treatment 3. Every 6 months for the next 3 years post treatment 4. Annually thereafter. |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 500 patients will be enrolled at 20-30 US sites. Patients have been diagnosed with persistent, refractory, or recurrent epithelial ovarian, peritoneal, or fallopian tube cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Rutherford, MD | Yale University | Principal Investigator |
| Hong Ma, MD | Precision Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Irvine | California | 92868 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14974761 | Background | 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. | |
| 12168915 | Background | 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. |
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Leftover tumor cells from the test, pathology slides, and blood samples will be collected and stored to look for potential genetic variations related to drug pathway genes to identify patterns associated with clinical outcome.
| Los Angeles |
| California |
| 90027 |
| United States |
| Yale University Medical Center | New Haven | Connecticut | 06520 | United States |
| Florida Gynecologic Oncology | Fort Myers | Florida | 33901 | United States |
| St. Vincents Medical Center | Jacksonville | Florida | 32204 | United States |
| The Florida Hospital | Orlando | Florida | 32804 | United States |
| Women's Cancer Associates | St. Petersburg | Florida | 33701 | United States |
| Atlanta Medical Center | Atlanta | Georgia | 30312 | United States |
| Southeastern Gynecologic Oncology Riverdale | Riverdale | Georgia | 30274 | United States |
| Northwestern University/Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| St. Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| St. Elizabeth Medical Center | Edgewood | Kentucky | 41017 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Saint Louis University | St Louis | Missouri | 63117 | United States |
| The Cooper Health System | Camden | New Jersey | 08103 | United States |
| Saint Barnabas Medical Center | West Orange | New Jersey | 07052 | United States |
| Schwartz Gynecologic Oncology, PLLC | Brightwaters | New York | 11718 | United States |
| University of Cincinnati Medical Center Barrett Cancer Center | Cincinnati | Ohio | 45219 | United States |
| University Hospital Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73190 | United States |
| Legacy Health System | Portland | Oregon | 97227 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| UPMC Cancer Center at Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Lankenau Hospital, Mainline Health System | Wynnwood | Pennsylvania | 19096 | United States |
| Women & Infants Hospital | Providence | Rhode Island | 02905-2499 | United States |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29605 | United States |
| ACORN - The West Clinic | Memphis | Tennessee | 38138 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| University of Wisconsin, Madison | Madison | Wisconsin | 53715 | United States |
| 11606094 | Background | 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. |
| 15212705 | Background | 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. |
| Background | Kaplan EL, Meier P. Nonparametric estimation of incomplete observations. JASA 1958;43:457-481. |
| Background | Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 5074. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D012008 | Recurrence |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
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