A Phase II Clinical Trial of Neoadjuvant Chemotherapy With M-VAC Plus Avastin in Patients With Locally Advanced Urothelial Cancer
Avastin is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels. Methotrexate, vinblastine, and doxorubicin are designed to disrupt
the growth of cancer cells, which causes cancer cells to start to die. Cisplatin has an
atom at its center that contains platinum. The platinum is designed to poison the cancer
cells, which may cause them to eventually die.
If you are found to be eligible to take part in this study, you will be treated with the
combination of Avastin, methotrexate, vinblastine, doxorubicin, and cisplatin. The study
drugs and saline will be given through a needle in your vein. Avastin will be given over 90
minutes. Methotrexate will be given over 30 minutes. Vinblastine will be given over 30
minutes. Doxorubicin will be given over 15 minutes. Cisplatin will be given over 4 hours.
You will also receive saline for hydration after you have completed the infusion of
cisplatin. This will take up to 20 hours. If you have a catheter in place, the chemotherapy
drugs as well as the saline will be given through the catheter. You will receive the study
drugs 1 time every 2 weeks. Every 2 weeks is called a study "cycle".
On Day 1 of each cycle, you will have a physical exam, including measurement of your vital
signs, height, and weight. You will be asked about any side effects you have experienced
since your last visit. Blood (about 2 teaspoons) and urine will be collected for routine
After 3 cycles of therapy, you will have a bone scan if your screening test showed signs of
bone disease. You will also have a repeat cystoscopy. These tests will be done to check the
status of the disease.
You will receive a total of 4 cycles of chemotherapy. At least 6 weeks after the last dose
of Avastin, you will have a cystectomy (removal of your tumor). Your doctor will explain
this procedure to you in detail. You will sign a separate consent form for this procedure.
After surgery, if you do not have disease in your lymph nodes or other sites, you will be
After surgery, if you still have disease in your lymph nodes or other sites, you will be
eligible to continue treatment with Avastin. Therapy can be restarted no sooner than 28
days after your surgery. You will receive Avastin every 2 or 3 weeks through a needle in
your vein. Every 2 or 3 weeks will be considered a study cycle.
Before each cycle of treatment, blood (about 1 teaspoon) will be drawn for routine tests.
Urine will be collected every cycle for routine testing. Every 3 months you will have a CT
scan or MRI to check the status of the disease.
You may continue to receive the study drug for up to 18 months of therapy. You will be
taken off study in the disease gets worse or intolerable side effects occur.
Once you are off-study, you will have long term follow-up visits every 3-6 months for the
first 30 months and then every year after that. These visits will continue for up to 4
years, or longer if your doctor thinks it is necessary. At these visits, you will have a CT
or MRI scan of your abdomen and pelvis and a chest x-ray. Blood (about 1 teaspoons) will be
drawn for routine testing.
This is an investigational study. Avastin is not FDA approved or commercially available for
this indication. Its use in this study is considered to be investigational. Methotrexate,
doxorubicin, vinblastine, and cisplatin are all FDA approved and commercially available. Up
to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Response
Response defined as the absence of residual muscle invasive cancer in the resected specimen.
Following 18 months of therapy
Arlene Siefker-Radtke, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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