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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.


N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

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Trial Information

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.


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Thomas J Rutherford, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

PT-301

NCT ID:

NCT00288275

Start Date:

July 2004

Completion Date:

October 2012

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Assay
  • Chemotherapy
  • Recurrent
  • Refractory
  • Persistent
  • Chemoresponse
  • Sensitivity
  • Precision Therapeutics
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Abington Memorial HospitalAbington, Pennsylvania  19001
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
St. Elizabeth Medical CenterEdgewood, Kentucky  41017
Cancer Centers of the CarolinasGreenville, South Carolina  29605
University of MinnesotaMinneapolis, Minnesota  55455
Saint Louis UniversitySt. Louis, Missouri  63104
Cleveland ClinicCleveland, Ohio  44195
Washington UniversitySt. Louis, Missouri  63110
Kaiser PermanenteSacramento, California  
The Methodist HospitalHouston, Texas  77030
Florida Gynecologic OncologyFort Myers, Florida  33901
University of Wisconsin, MadisonMadison, Wisconsin  53792
Ut Southwestern Medical CenterDallas, Texas  75390
Saint Barnabas Medical CenterLivingston, New Jersey  07039
University of CaliforniaSan Francisco, California  94108
University of Virginia Health SystemCharlottesville, Virginia  22903
Women's Cancer AssociatesSaint Petersburg, Florida  33701
Schwartz Gynecologic Oncology, PLLCBabylon, New York  11702
Legacy Health SystemPortland, Oregon  97210
Yale University Medical CenterNew Haven, Connecticut  06520
St. Vincents Medical CenterJacksonville, Florida  32204
The Florida HospitalOrlando, Florida  32804
Atlanta Medical CenterAtlanta, Georgia  30312
Southeastern Gynecologic Oncology RiverdaleRiverdale, Georgia  30274
Rush UniversityChicago, Illinois  60612
Northwestern University/Prentice Women's HospitalChicago, Illinois  60611
The Cooper Health SystemCamden, New Jersey  08103
University of Cincinnati Medical Center Barrett Cancer CenterCincinnati, Ohio  45219
University Hospital Case Medical CenterCleveland, Ohio  44106
University of Toledo Medical CenterToledo, Ohio  43614
UPMC Cancer Center at Magee Womens HospitalPittsburgh, Pennsylvania  15213
Lankenau Hospital, Mainline Health SystemWynnwood, Pennsylvania  19096
Women & Infants HospitalProvidence, Rhode Island  02905-2499
ACORN - The West ClinicMemphis, Tennessee  38138