Clinical trial NCT01295489: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fallopian Tube Carcinoma
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-02-14
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE

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.

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

Primary outcomes:
measure: Amount of peritoneal fluid obtained during each attempted extraction of peritoneal fluid or washing
timeFrame: Up to 1 year
measure: Presence of immune cells measured by immunohistochemistry in archival formalin-fixed, paraffin-embedded tumor tissue
timeFrame: Up to 1 year
measure: Quantity of each type of immune cells identified in the peritoneal fluid or washings specimens
timeFrame: Up to 1 year
measure: Quantity of each type of mononuclear cells in peripheral blood
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hinsdale
country: United States
facility: Sudarshan K Sharma MD Limted-Gynecologic Oncology
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Ames
country: United States
facility: McFarland Clinic PC-William R Bliss Cancer Center
state: Iowa
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute-Tulsa
state: Oklahoma
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: NRG Oncology
name: Robert Edwards
role: PRINCIPAL_INVESTIGATOR
References: