Brief Title
Biomarkers in Patients With Previously Untreated Invasive Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
A Study of the Local and Systemic Effects of Intraperitoneal Chemotherapy in the Treatment of Previously-Untreated, Invasive Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Brief Summary
This research trial studies biomarkers in patients with previously untreated invasive ovarian
epithelial, fallopian tube, or primary peritoneal cancer. Studying samples of tumor tissue,
peritoneal cavity fluid, and blood from patients receiving chemotherapy directly into the
abdominal cavity (intraperitoneal) may help doctors learn more about the effects of
intraperitoneal chemotherapy on cells. It may also help doctors identify and learn more about
biomarkers related to cancer.
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Type
Observational
Primary Outcome
Amount of peritoneal fluid obtained during each attempted extraction of peritoneal fluid or washing
Condition
Fallopian Tube Carcinoma
Intervention
Laboratory Biomarker Analysis
Study Arms / Comparison Groups
Group A (IP catheter removed)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
39
Start Date
March 2011
Primary Completion Date
January 2018
Eligibility Criteria
Inclusion Criteria:
- Patients must be enrolled on GOG-0252
- 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 are not enrolled on GOG-0252
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Robert Edwards, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01295489
Organization ID
GOG-0271
Secondary IDs
NCI-2011-02871
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Robert Edwards, Principal Investigator, NRG Oncology
Verification Date
May 2018