A Phase II Evaluation of Bevacizumab and Paclitaxel in Patients With Recurrent Small Cell, Large Cell, and Neuroendocrine Tumors of the Cervix and Uterus
The Study Drugs:
Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may
cause them to die.
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
effects of Vascular endothelial growth factor (VEGF), a blood-vessel stimulating agent that
plays an important role in the growth of both normal and abnormal blood vessels.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Days 1, 8, 15, and 22 of each
28-day study "cycle", you will receive paclitaxel through a needle into your vein over 1
hour.
On Days 1 and 15 of each cycle, you will receive bevacizumab by vein. The first dose of
bevacizumab will be given over about 90 minutes. If the first dose is well tolerated, the
second dose may be given over about 60 minutes. If this is well tolerated, the third and any
other doses may be given over about 30 minutes.
Before you receive the study drugs, you will receive premedication (selected by your doctor)
to help prevent or lessen any side effects from the study drugs.
Study Visits:
About every 4 weeks, the following tests and procedures will be performed:
- You will have a physical exam, including a pelvic exam and measurement of your vital
signs.
- You will have a performance status evaluation.
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test how your blood
clots.
- You will be asked if you have experienced any side effects.
About every 8 weeks, you will have a chest x-ray and a computed tomography (CT) or magnetic
resonance imaging (MRI) scan of your abdomen and pelvis to check the status of the disease.
Length of Study:
You may stay on study for as long as you are benefitting. You will be taken off study early
if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit, the following
tests and procedures will be performed:
- You will have a physical exam, including a pelvic exam and measurement of your vital
signs.
- You will have a performance status evaluation.
- Blood (about 2-3 teaspoons) will be drawn for routine tests and possibly blood
clotting tests.
- You will have a CT or MRI of the abdomen and pelvis to check the status of the disease.
- You will be asked if you have experienced any side effects.
This is an investigational study. Paclitaxel is FDA approved and commercially available for
the treatment of breast cancer, nonsmall cell lung cancer, ovarian cancers, and treatment of
AIDS-related Kaposi's sarcoma (KS). Bevacizumab is FDA approved and commercially available
for use in combination with chemotherapy in patients with colon cancer, but its use in this
combination for this type of cancer is considered experimental.
Up to 20 participants will take part in this study. All will be enrolled at M. D. Anderson.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Baseline to 6 Months, or disease progression.
No
Michael M. Frumovitz, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2007-0324
NCT00626561
February 2008
July 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |