 |
Discover ~ Translate ~ Cure |
|
Discover ~ Translate ~ Cure |
| Title |
| A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) with Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum- Resistant Epithelial Ovarian Cancer |
| Study Design |
| Abraxane will be administered by IV infusion over 30 minutes once a week for 3 weeks with one week off between each cycle (minimum of 4 cycles unless disease progression)
GM-CSF will be self-administered by subcutaneous injection daily for the last two weeks of each cycle |
| Study Contact |
| Nicole Bates | 866.932.8588 | E-Mail |
| Patient Population |
| Ovarian cancer: Platinum-resistant or platinum refractory disease with an elevated CA125 level on at least two occasions. |
| Number of Patients: This study will accrue a maximum of 30 patients. |
Patients Visits
|
Other Procedures
|
| Objectives |
Primary:
|
Secondary:
|
| Other Notes |
| Abraxane™ is FDA Approved Abraxane™ (Paclitaxel protein-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Abraxane ™ is not FDA approved to treat ovarian cancer. |
| Abraxane ™ is a chemotherapy drug Abraxane ™ belongs to a class of chemotherapy drugs called plant alkaloids. Plant alkaloids are made from plants. Taxanes are also known as antimicrotubule agents. The plant alkaloids are cell-cycle specific. This means they attack the cells during various phases of division. Antimicrotubule agents (such as paclitaxel), inhibit the microtubule structures within the cell. Microtubules are part of the cell's apparatus for dividing and replicating itself. Inhibition of these structures ultimately results in cell death. |
| GM-CSF is FDA Approved GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) is used to accelerate the recovery of white blood cells following chemotherapy. It is also used following induction chemotherapy in Acute Myelogenous Leukemia (AML), after bone marrow transplantation, and before and/or after peripheral blood stem cell transplantation. GM-CSF is not FDA approved to treat cancer. |
| GM-CSF is a biologic response modifier It is classified as a colony stimulating factor. GM-CSF is a growth factor that stimulates the production, maturation and activation of three types of white blood cells: neutrophils, macrophages and dendritic cells. Each of these three cells has a distinct purpose and function within the immune system. Neutrophils are the most abundant WBC and are the first to respond to the site of an infection. Their purpose is to capture and digest foreign invaders such as bacteria. Macrophages also capture and digest foreign invaders but are longer acting and recognize more invaders than neutrophils. Dendritic cells make up less than 1% of WBC's but are extremely important. They continuously scan their environment and alert other cells when they find something foreign such as an infection. |
| Start Date: September 2005 |
| Study Location: University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195 |
| Current Enrollment: 13% |
| Scientific Description |
| ClinicalTrials.gov Identifier: NCT00466960 |
Page last updated 4/27/09 |