Clinical Trial: Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) With Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum-Refractory/Resistant Epithelial

Brief Summary:

RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing and may also increase the number of immune cells found in bone marrow or peripheral blood and help the immune system recover from the side effects of chemotherapy. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to previous chemotherapy


Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine whether chronic GM-CSF administration during and after cytotoxic chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer remission than experienced in the most recent platinum-containing regimen.

SECONDARY OBJECTIVES:

I. To determine the extent to which chronic GM-CSF administration can increase the number of activated monocytes in patients with advanced stage epithelial ovarian cancer.

II. To determine the extent to which chronic GM-CSF administration can increase the number and activation state of peripheral circulating antigen presenting cells, such as dendritic cells and activated monocytes, in patients with advanced epithelial ovarian cancer.

III. To determine the extent to which chronic GM-CSF administration can increase the number and functional status of T cells that recognize tumor specific antigens in patients with advanced stage epithelial ovarian cancer.

IV. To determine the extent to which chronic GM-CSF administration can increase the number and functional status of antigen specific T cells that recognize foreign pathogens in patients with advanced stage epithelial ovarian cancer.

OUTLINE:

INDUCTION THERAPY: Patients receive GM-CSF subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

  • Time to progression [ Time Frame: Up to 5 years ]
  • Response rate [ Time Frame: Up to 5 years ]


    • Original Primary Outcome:

    • Clinical response
    • Time to progression


    Current Secondary Outcome:

    • Correlation between circulating monocytes and time to progression [ Time Frame: At day 1 of induction therapy, days 1-7 of maintenance therapy, 6 months after induction therapy, and at end of study ]
    • Correlation between circulating dendritic cell count and maturation state with clinical response and response duration [ Time Frame: At day 1 of induction therapy, days 1-7 of maintenance therapy, 6 months after induction therapy, and at end of study ]
    • Precursor frequency of circulating activated T lymphocytes against common ovarian cancer tumor associated antigens to measure the development of immunity to anti-tumor antigens [ Time Frame: During treatment with chemotherapy and GM-CSF ]
    • Precursor frequency of circulating T lymphocytes activated against foreign antigens [ Time Frame: At day 1 of induction therapy, days 1-7 of maintenance therapy, 6 months after induction therapy, and at end of study ]


    Original Secondary Outcome:

    • Correlation between circulating monocytes with time to progression
    • Correlation between circulating dendritic cell count and maturation state with clinical response and response duration
    • Precursor frequency of circulating activated T lymphocytes against common ovarian cancer tumor associated antigens to measure the development of immunity to anti-tumor antigens
    • Precursor frequency of circulating T lymphocytes activated against foreign antigens (tt, influenza)


    Information By: University of Washington

    Dates:
    Date Received: April 25, 2007
    Date Started: May 2006
    Date Completion:
    Last Updated: January 15, 2014
    Last Verified: January 2014