Primary Peritoneal Carcinoma Clinical Trial
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
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.
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.
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