A Phase I Study Evaluating the Safety and Tolerability of PS-341(Bortezomib)and Carboplatin in Patients With Platinum- and Taxane-Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
Bortezomib is a drug that turns off certain genes and proteins inside the cancer cell that
are responsible for cell growth. Researchers believe that when certain genes and proteins
are turned off, the ability of the cancer cell to survive is decreased.
Before treatment starts, participants will have a complete checkup, blood tests, a urine
test, a heart test, a chest x-ray, and either a CT scan or MRI scan. Women able to have
children must have a negative blood pregnancy test within 14 days of beginning treatment.
Blood tests and a complete checkup will also be done before each course of therapy and a
month after treatment ends. Approximately 2-3 teaspoons of blood will be obtained for
routine blood tests each time blood is drawn during this study.
Participants in this study will receive Bortezomib and carboplatin through a catheter (tube)
placed in a vein. This is Day 1 of therapy. Bortezomib is given first (over 5 to 10 seconds)
followed by carboplatin (over one hour). Bortezomib is then given alone on Days 4, 8, and
11. There is no treatment given on Days 12-28. One course of therapy is 28 days long and
includes one dose of carboplatin and 4 doses of Bortezomib. All treatment is given on an
outpatient basis at M. D. Anderson.
There are 4 different dose levels of Bortezomib being studied. The dose of Bortezomib that
participants receive will depend on when they are enrolled. It will also depend on whether
or not other participants had side effects from their treatment. Up to 6 patients could be
treated at each dose.
Before each course of therapy, participants will have a physical exam and blood tests. A CT
scan or MRI scan is repeated after Cycles 2 and 4 and at the end of treatment. Participants
who have a partial or complete response (the tumor shrinks by more than 50% or disappears
completely) will have a repeat CT or MRI 4 weeks later to confirm the response.
Participants may receive up to 8 courses of treatment. If the disease gets worse or if
intolerable side effects occur, participants will be taken off study.
This is an investigational study. Bortezomib is approved for use by the FDA, in patients
with multiple myeloma. Carboplatin is approved by the FDA, though its use with Bortezomib is
experimental. A total of 24 patients will take part in this study. All will be enrolled at
M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Bortezomib with Carboplatin Chemotherapy
Assessed Day 21 of each 28 Day cycle, up to 4 cohorts for a total of 8 cycles
Pedro T. Ramirez, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas M. D. Anderson Cancer Center||Houston, Texas 77030|