Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer

Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00288275
• Other study ID #: PT-301
• Status: Terminated
• Phase: N/A
• First received: February 3, 2006
• Last updated: October 4, 2012
• Start date: July 2004
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Precision Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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. 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.

Other known NCT identifiers

• NCT00301717

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 256
• Est. completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Atlanta Medical Center	Atlanta	Georgia
United States	Schwartz Gynecologic Oncology, PLLC	Brightwaters	New York
United States	The Cooper Health System	Camden	New Jersey
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Northwestern University/Prentice Women's Hospital	Chicago	Illinois
United States	Rush University	Chicago	Illinois
United States	University of Cincinnati Medical Center Barrett Cancer Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospital Case Medical Center	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	St. Elizabeth Medical Center	Edgewood	Kentucky
United States	Florida Gynecologic Oncology	Fort Myers	Florida
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	The Methodist Hospital	Houston	Texas
United States	St. Vincent Indianapolis Hospital	Indianapolis	Indiana
United States	University of California	Irvine	California
United States	St. Vincents Medical Center	Jacksonville	Florida
United States	Kaiser Permanente	Los Angeles	California
United States	University of Wisconsin, Madison	Madison	Wisconsin
United States	ACORN - The West Clinic	Memphis	Tennessee
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Yale University Medical Center	New Haven	Connecticut
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	The Florida Hospital	Orlando	Florida
United States	UPMC Cancer Center at Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Legacy Health System	Portland	Oregon
United States	Women & Infants Hospital	Providence	Rhode Island
United States	Southeastern Gynecologic Oncology Riverdale	Riverdale	Georgia
United States	Saint Louis University	St. Louis	Missouri
United States	Washington University	St. Louis	Missouri
United States	Women's Cancer Associates	St. Petersburg	Florida
United States	University of Toledo Medical Center	Toledo	Ohio
United States	Saint Barnabas Medical Center	West Orange	New Jersey
United States	Lankenau Hospital, Mainline Health System	Wynnwood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Precision Therapeutics

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 5074.

Kaplan EL, Meier P. Nonparametric estimation of incomplete observations. JASA 1958;43:457-481.

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. — View Citation

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. — View Citation

O'Meara AT, Sevin BU. Predictive value of the ATP chemosensitivity assay in epithelial ovarian cancer. Gynecol Oncol. 2001 Nov;83(2):334-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No