Status:
TERMINATED
Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer
Lead Sponsor:
Precision Therapeutics
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
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 ind...
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. Unfor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00288275
Start Date
July 1 2004
End Date
October 1 2012
Last Update
October 5 2012
Active Locations (36)
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1
University of California
Irvine, California, United States, 92868
2
Kaiser Permanente
Los Angeles, California, United States, 90027
3
Yale University Medical Center
New Haven, Connecticut, United States, 06520
4
Florida Gynecologic Oncology
Fort Myers, Florida, United States, 33901