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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01295489
First received: February 11, 2011
Last updated: February 27, 2014
Last verified: February 2014

February 11, 2011
February 27, 2014
April 2011
September 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01295489 on ClinicalTrials.gov Archive Site
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Biomarkers in Patients With Previously Untreated Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
A Limited Institution 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

RATIONALE: Studying samples of tumor tissue, peritoneal cavity fluid, and blood from patients receiving intraperitoneal chemotherapy 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.

PURPOSE: This research study is studying biomarkers in patients with previously untreated invasive ovarian epithelial, fallopian tube, or peritoneal cancer.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with previously untreated invasive ovarian epithelial cancer

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Drug: intraperitoneal chemotherapy
  • Genetic: gene expression analysis
  • Genetic: protein analysis
  • Other: flow cytometry
  • Other: immunoenzyme technique
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
39
Not Provided
September 2015   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of epithelial ovarian, fallopian tube, or peritoneal cancer

    • Newly diagnosed disease
    • Chemotherapy naïve
  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01295489
GOG-0271, CDR0000695260, NCI-2011-02871
Yes
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Robert P. Edwards, MD University of Pittsburgh
Gynecologic Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP