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Ovarian CancerNCT00288275

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

An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by Precision Therapeutics at 36 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
How many people
256 participants
Where
36 sitesUnited States
Study dates
Jul 2004to Oct 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Atlanta Medical Center

    Atlanta, Georgia, 30312

  • Schwartz Gynecologic Oncology, PLLC

    Brightwaters, New York, 11718

  • The Cooper Health System

    Camden, New Jersey, 08103

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Northwestern University/Prentice Women's Hospital

    Chicago, Illinois, 60611

  • Rush University

    Chicago, Illinois, 60612

  • University of Cincinnati Medical Center Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • University Hospital Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • St. Elizabeth Medical Center

    Edgewood, Kentucky, 41017

  • Florida Gynecologic Oncology

    Fort Myers, Florida, 33901

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • The Methodist Hospital

    Houston, Texas, 77030

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • University of California

    Irvine, California, 92868

  • St. Vincents Medical Center

    Jacksonville, Florida, 32204

  • Kaiser Permanente

    Los Angeles, California, 90027

  • University of Wisconsin, Madison

    Madison, Wisconsin, 53715

  • ACORN - The West Clinic

    Memphis, Tennessee, 38138

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale University Medical Center

    New Haven, Connecticut, 06520

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73190

  • The Florida Hospital

    Orlando, Florida, 32804

  • UPMC Cancer Center at Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Legacy Health System

    Portland, Oregon, 97227

  • Women & Infants Hospital

    Providence, Rhode Island, 02905-2499

  • Southeastern Gynecologic Oncology Riverdale

    Riverdale, Georgia, 30274

  • Washington University

    St Louis, Missouri, 63110

  • Saint Louis University

    St Louis, Missouri, 63117

  • Women's Cancer Associates

    St. Petersburg, Florida, 33701

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Saint Barnabas Medical Center

    West Orange, New Jersey, 07052

  • Lankenau Hospital, Mainline Health System

    Wynnwood, Pennsylvania, 19096

Other trials in United States

About this study

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.

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.

Read the 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. 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.

Keywords
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Assay, Chemotherapy, Recurrent, Refractory, Persistent, Chemoresponse, Sensitivity, Precision Therapeutics
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Recurrence, Hypersensitivity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Measured: 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)

  1. Tumor Response

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2006 (estimated)
  2. Study startJul 2004
  3. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00288275
Sponsor's protocol ID
PT-301
Status last verified
Oct 2012
First submitted
3 Feb 2006
Last updated
5 Oct 2012
Results posted
No

Publications

  • 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.

    PubMed 14974761

  • 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.

    PubMed 12168915

  • O'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.

    PubMed 11606094

  • 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. doi: 10.3816/ccc.2004.s.007.

    PubMed 15212705

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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by Precision Therapeutics at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00288275, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.

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