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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Practicality of recovering immune cells from peritoneal fluids for laboratory analysis using flow cytometry

Safety Issue:

No

Principal Investigator

Robert P. Edwards, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

Unspecified

Study ID:

CDR0000695260

NCT ID:

NCT01295489

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IIA primary peritoneal cavity cancer
  • stage IIB primary peritoneal cavity cancer
  • stage IIC primary peritoneal cavity cancer
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • stage IIA ovarian epithelial cancer
  • stage IIB ovarian epithelial cancer
  • stage IIC ovarian epithelial cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IIA fallopian tube cancer
  • stage IIB fallopian tube cancer
  • stage IIC fallopian tube cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IV fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
McFarland Clinic, PCAmes, Iowa  50010
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Gynecologic OncologyHinsdale, Illinois  60521