Biomarkers in Patients With Previously Untreated Invasive Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
NCT ID: NCT01295489
Last Updated: 2018-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
39 participants
OBSERVATIONAL
2011-03-31
Brief Summary
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Detailed Description
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I. To determine the feasibility of obtaining peritoneal fluid, peritoneal washings, and peripheral blood in patients receiving intraperitoneal (IP) chemotherapy for ovarian cancer at multiple institutions.
II. Assess the recovery and viability of peripheral blood mononuclear cells and immune cell subsets in peritoneal fluid and washings.
III. Assess the amount of peritoneal fluid that can be obtained pre-treatment and at specified time points during the course of IP chemotherapy.
IV. Quantify the type and number of cells in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane based IP chemotherapy.
V. Determine the levels of immunomodulatory cytokines in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane based IP chemotherapy.
VI. Generate exploratory information on the impact of platinum and taxane based IP chemotherapy on immunomodulatory cytokines and tumor-associated alterations in cell phenotypes of peritoneal fluid, peritoneal washings, and blood.
VII. To determine the feasibility of obtaining peritoneal fluid, peritoneal washings, and peripheral blood in patients receiving intravenous (IV) chemotherapy for ovarian cancer at multiple institutions (limited to patients that receive an IP catheter at the time of surgery and the catheter is left in by the investigator, but are subsequently treated with IV chemotherapy).
VIII. Assess the amount of peritoneal fluid that can be obtained pre-treatment and at specified time points during the course of IV chemotherapy.
IX. Assess the recovery and viability of peripheral blood mononuclear cells and immune cell subsets in peritoneal fluid and washings.
X. Quantify the type and number of immune cells in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane based IV chemotherapy.
XI. Determine levels of immunomodulatory cytokines in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane-based IV chemotherapy.
XII. Generate exploratory information on the impact of platinum and taxane based IV chemotherapy on immunomodulatory cytokines tumor-associated alterations in cell phenotypes of peritoneal fluid, peritoneal washings, and blood.
XIII. Explore whether there is a relationship between immune cell populations measured in peripheral blood, peritoneal fluid, and peritoneal washings AND immune cell subsets measured by immunohistochemistry in archival formalin-fixed, paraffin-embedded tumor tissue.
OUTLINE: Patients are assigned to a group based on which arm of treatment they are randomized to receive on Gynecologic Oncology Group (GOG)-0252.
GROUP A (IP CATHETER REMOVED): Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and blood (for cell, plasma, and serum isolations) is collected before courses two and three for translational research.
GROUP B (IP CATHETER IN PLACE): Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolations) before courses two and three for translational research.
Conditions
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Study Groups
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Group A (IP catheter removed)
Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and blood (for cell, plasma, and serum isolations) is collected before courses two and three for translational research.
Laboratory Biomarker Analysis
Correlative studies
Group B (IP catheter in place)
Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolations) before courses two and three for translational research.
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* Patients must have an IP catheter placed prior to initiating platinum and taxane-based chemotherapy on GOG-0252
* Patients must have signed an approved informed consent for specimen collection and participation in this translational research study
Exclusion Criteria
* Patients who have not had an IP catheter placed prior to initiating platinum and taxane-based IP chemotherapy on GOG-0252
* Patients who did not sign an approved informed consent for specimen collection and participation in this translational research study
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Robert Edwards
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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NCI-2011-02871
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000695260
Identifier Type: -
Identifier Source: secondary_id
GOG-0271
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0271
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0271
Identifier Type: -
Identifier Source: org_study_id
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