Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer
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.
1 other identifier
observational
256
1 country
36
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2004
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 3, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 5, 2012
October 1, 2012
February 3, 2006
October 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
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.
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
University of California
Irvine, California, 92868, United States
Kaiser Permanente
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
Related Publications (6)
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.
PMID: 14974761BACKGROUNDNess 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.
PMID: 12168915BACKGROUNDO'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.
PMID: 11606094BACKGROUNDMcLeod 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.
PMID: 15212705BACKGROUNDKaplan EL, Meier P. Nonparametric estimation of incomplete observations. JASA 1958;43:457-481.
BACKGROUNDJournal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 5074.
BACKGROUND
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas J Rutherford, MD
Yale University
- STUDY DIRECTOR
Hong Ma, MD
Precision Therapeutics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2006
First Posted
February 7, 2006
Study Start
July 1, 2004
Study Completion
October 1, 2012
Last Updated
October 5, 2012
Record last verified: 2012-10