A Phase I/II Study of Weekly Topotecan and Gefitinib (Iressa) in Patients With Platinum-Resistant Ovarian, Peritoneal, of Fallopian Tube Cancer
Gefitinib inhibits the activity of a molecule present on the cancer cell that plays a role
in cancer cell growth. Topotecan is an FDA approved drug used to treat ovarian cancer that
is still present after treatment with chemotherapy. It is also used to treat recurrent
ovarian cancer (patients whose cancer returns after they have been cancer-free for a period
Before treatment starts, you will have a complete physical exam, routine blood tests (about
2-3 teaspoons), a chest x-ray, and a CT scan or MRI. Women who are able to have children
must have a negative blood pregnancy test.
There are 2 phases to this study. In the first phase, 3 different dose levels of topotecan
are being studied. The dose of topotecan that you receive will depend on when you are
enrolled. It will also depend on whether or not other participants had side effects from
their treatment. Although the dose of topotecan will vary, the dose of gefitinib is the same
for all participants. Up to 6 participants may be treated at each dose. The goal of this
portion of the study is to find the highest safe dose of this drug combination. Up to 18
patients will be treated on this part of the study.
Once the highest safe dose of topotecan has been found, the second phase of the study will
begin. In this phase, all participants will receive the same dose of topotecan and
gefitinib. Up to 40 patients will be enrolled in this part of the study (but 6 will be from
the 1st portion of the study.
Each treatment cycle is 28 days long. You will take one gefitinib tablet by mouth every day
beginning on Day 1. In addition, you will be given topotecan through a catheter (tube)
placed in a vein over 30 minutes on Days 1, 8, and 15.
Blood tests to check your kidney, liver, and bone marrow function and a complete checkup
(physical examination, including a pelvic and rectal exam) will be done before each course
of therapy and a month after treatment ends. About 2-3 teaspoons of blood will be collected
for routine blood tests each time blood is drawn during this study. Follow up CT scans or
MRI scans will be done after every 2 to 3 cycles to evaluate your response to treatment.
You will be taken off study if your disease gets worse or intolerable side effects occur. If
you have a complete response to this therapy (no evidence of cancer) then treatment will
continue for an additional 6 months and then stop. All treatment is given on an outpatient
basis at UTMDACC.
You will be monitored for at least 30 days after your last dose of therapy. If you have side
effects related to this treatment combination, you will be monitored longer (until the side
effects have gone away).
This is an investigational study. Both gefitinib and topotecan are FDA approved and
commercially available. However, their use together in this study is investigational. A
total of up to 52 patients will take part in this study. All will be enrolled at UTMDACC.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicity
Continual reassessment method, prior to each 28 day cycle
Judith Wolf, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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