A Phase II Trial of Bevacizumab With Carboplatin and Weekly Paclitaxel as First-Line Treatment in Epithelial Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma
Standard chemotherapy for newly diagnosed epithelial ovarian, primary peritoneal, or
fallopian tube cancer is usually a combination of 2 chemotherapy drugs called carboplatin
and paclitaxel. This treatment has been found to be effective, but the cancer often comes
back, requiring additional treatment. For this study, researchers will give carboplatin,
bevacizumab, and weekly paclitaxel to see if the treatment is effective and safe in treating
the disease.
The Study Drugs:
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary
for tumor growth. This may prevent or slow down the growth of cancer cells.
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell
division.
Paclitaxel is designed to block the mechanisms of cell division in cancer cells, causing
them to die.
Study Drug Administration:
If you choose to take part in this study, you will receive up to 6 "cycles" of treatment
with the study drugs. Each cycle is 21 days (3 weeks) long.
On Day 1 of Cycle 1, you will receive paclitaxel and carboplatin by vein. Paclitaxel is
given first over about 3 hours, followed by carboplatin over about 1 hour.
On Days 8 and 15 of Cycle 1, you will only receive paclitaxel by vein over about 3 hours.
On Day 1 of Cycles 2-6, you will receive paclitaxel, carboplatin, and bevacizumab by vein.
Paclitaxel is given first over about 3 hours, followed by carboplatin over about 1 hour, and
then bevacizumab over about 1 ½ hours.
If you tolerate your first dose of bevacizumab well, the dose of bevacizumab during Cycle 3
may be given over 60 minutes. If you tolerate the 60 minute dose well, the bevacizumab
doses during Cycles 4, 5, and 6 may be given over 30 minutes.
On Days 8 and 15 of Cycles 2-6, you will only receive paclitaxel by vein over about 3 hours.
Before you begin each treatment, you will receive the drug dexamethasone by vein to help
decrease the risk of study drug side effects. If the study doctor thinks it is needed, you
may also receive other drugs (such as cimetidine and diphenhydramine) by vein to help
prevent side effects such as nausea and allergic reaction.
Study Visits:
Before starting each cycle:
- Your medical history will be recorded, including a list of any drugs you may be taking.
- Your performance status will be recorded.
- You will have a physical exam, including measurement of weight and vital signs.
- A pelvic exam will be performed if the study doctor thinks it is necessary.
- You will be asked about any side effects you may be experiencing.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn to measure levels of CA125.
- If the study doctor thinks it is necessary, you will have a CT or MRI scan of the
abdomen and pelvis.
Before Cycles 2, 4, and 6 only, urine will be collected for routine tests.
Length of Study:
You may remain on study for up to 6 cycles. You will be taken off study early if the
disease gets worse or you experience any intolerable side effects.
End-of-Study Visit:
Within 4 weeks after your last dose of study drugs, you will have an end-of-study visit, at
which the following tests and procedures will be performed:
- Your medical history will be recorded, including a list of any drugs you may be taking.
- You will have a physical exam, including measurement of weight, vital signs, and a
pelvic exam.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests and to measure levels of
CA125.
- Urine will be collected for routine tests.
- You will have a CT scan or MRI scan of the abdomen and pelvis.
- If the study doctor thinks it is necessary, you will have a chest x-ray and/or an ECG.
Long-Term Follow-Up:
After your end-of-study visit, you will have long-term follow-up visits every 3 months for 2
years, at which the following tests and procedures will be performed:
- Your medical history will be recorded, including a list of any drugs you may be taking.
- You will have a physical exam, including measurement of weight, vital signs, and a
pelvic exam.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests and to measure levels of
CA125.
- Urine will be collected for routine tests.
- You will have a CT scan or MRI scan of the abdomen and pelvis.
- If the study doctor thinks it is necessary, you will have a chest x-ray and/or an ECG.
If you are unable to come to M. D. Anderson for your long-term follow-up visits, researchers
will call you on the phone every 3 months for 2 years to ask you questions about how you are
doing. Your doctor will tell you if any standard tests and procedures need to be performed.
The phone calls should last about 10 minutes each time.
This is an investigational study. Bevacizumab, carboplatin, and paclitaxel are each FDA
approved and commercially available for the treatment of many types of cancer. The
combination of carboplatin and paclitaxel is FDA approved and commercially available for the
treatment of epithelial ovarian, primary peritoneal, or fallopian tube cancer. At this
time, the addition of bevacizumab to the combination of carboplatin and paclitaxel is not
FDA approved and is being used in research only.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Treatment Success
Treatment Success is defined as a patient completing at least 4 cycles of combination therapy (Bevacizumab with Carboplatin and weekly Paclitaxel) regardless of delay or dose modification.
4 cycles of 21 days
Yes
Anil Sood, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0186
NCT01097746
April 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |