Clinical trial NCT00626561
Conditions: Cervical Cancer Uterine Cancer
Keywords: Cervical Cancer Uterine Cancer Bevacizumab Avastin Anti-VEGF monoclonal antibody rhuMAb-VEGF Paclitaxel Taxol
Sponsor: M.D. Anderson Cancer Center
Start date: 2008-02-01; Completion date: 2011-07-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives:

Primary:

To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by progression-free survival.

Secondary:

1. To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by overall survival.
2. To determine the response rates in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
3. To characterize the quality of life (QoL) in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
4. To determine the nature and degree of toxicity in patients with advanced or recurrent small cell, large cell, or neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.

Detailed description:
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.

Arms: arm 1: Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m\^2 IV weekly.
Interventions: intervention 1: Bevacizumab intervention 2: Paclitaxel
Intervention descriptions: intervention 1: 10 mg/kg IV twice weekly on days 1 and 15. intervention 2: 60 mg/m\^2 IV weekly on days 1, 8, 15, and 22.

Protocol documents: