Biomarkers in Patients With Previously Untreated Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

• Practicality of recovering immune cells from peritoneal fluids for laboratory analysis using flow cytometry [ Designated as safety issue: No ]
  
• Amount of peritoneal fluid obtained during each attempted extraction of peritoneal fluid or washing [ Designated as safety issue: No ]
  
• Quantity of each type of immune cells identified in the peritoneal fluid or washings specimens [ Designated as safety issue: No ]
  
• Quantity of each type of mononuclear cells in peripheral blood [ Designated as safety issue: No ]
  
• Presence of immune cells measured by immunohistochemistry in archival formalin-fixed, paraffin-embedded tumor tissue [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the feasibility of obtaining peritoneal fluid, peritoneal washings, and peripheral blood in patients receiving intraperitoneal (IP) chemotherapy for ovarian cancer at multiple institutions.
• Assess the recovery and viability of peripheral blood mononuclear cells and immune cell subsets in peritoneal fluid and washings.
• Assess the amount of peritoneal fluid that can be obtained pre-treatment and at specified time points during the course of IP chemotherapy.
• 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.
• 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.
• 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.
• 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).
• Assess the amount of peritoneal fluid that can be obtained pre-treatment and at specified time points during the course of IV chemotherapy.
• Assess the recovery and viability of peripheral blood mononuclear cells and immune cell subsets in peritoneal fluid and washings.
• 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.
• 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.
• 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.
• 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: This is a multicenter study. Patients are assigned to a group based on which arm of treatment they are randomized to receive on 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.