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| Sponsor: | Precision Therapeutics |
|---|---|
| Information provided by (Responsible Party): | Precision Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00288275 |
Purpose
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.
| Condition |
|---|
|
Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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. |
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.
| Estimated Enrollment: | 256 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | June 2013 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 36 Study Locations| Principal Investigator: | Thomas J Rutherford, MD | Yale University |
| Study Director: | Hong Ma, MD | Precision Therapeutics, Inc. |
More Information
| Responsible Party: | Precision Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00288275 History of Changes |
| Obsolete Identifiers: | NCT00301717 |
| Other Study ID Numbers: | PT-301 |
| Study First Received: | February 3, 2006 |
| Last Updated: | January 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Assay Chemotherapy Recurrent |
Refractory Persistent Chemoresponse Sensitivity Precision Therapeutics |
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Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |