Pre-Operative Chemoradiation Followed by Post-Operative Tetrathiomolybdate (TM) in Patients With Loco-Regional Esophageal Carcinoma (UMCC 2001-007)
The pre-study evaluations include a medical history, physical examination, blood laboratory
evaluations, and scans to evaluate disease. A CT scan will be performed to measure the size
of the subject's tumor(s). The treatment phase of the study includes: 1. Administration
of Paclitaxel as an intravenous infusion over 1 hour on Days #1, 8, 15, and 22. 2.
Cisplatin will be given as an intravenous infusion after Paclitaxel over 1 hour on Days #1
and 22. 3. Radiation treatments twice per day with each dose separated by more than 6
hours, on Days 1-5, 8-12 and 15-19.
The subject's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
Approximately four to six weeks after surgery, the subject will start taking
Tetrathiomolybdate, one pill a day by mouth, for two years or until treatment is no longer
working to control your cancer. The dose may need to be increased by 1 pill every 2 weeks,
depending on the results of blood tests that are given on a routine basis to help guide the
Dietary Restrictions: Subjects may not eat shell fish or liver (organ meat) while on study
due to high copper content.
Blood draws (approximately 1-2 tablespoons) will be taken weekly while the subject is
undergoing chemotherapy and radiation prior to surgery. Prior to your surgery a CT scan
will also be administered. Four to six weeks after surgery (when the subject is starting to
take Tetrathiomolybdate), a blood test (approximately 1 teaspoon) will be performed every
other week for 2 times, and monthly thereafter. This blood test will check for the amount
of copper in the subject's blood. When the level of copper has been lowered sufficiently
(which will be determined by your physician) an additional blood test and a baseline chest
x-ray will be obtained.
Additional blood will be drawn (approximately 1-2 tablespoons) and tested every 6 months for
the first 2 years.
There are circumstances under which treatment may be discontinued whether the subject agrees
or not. These circumstances include: the subject's tumor gets worse despite the treatment;
side effects of the treatment are too dangerous for the subject; new information about the
drug becomes available and this information suggests the drug will be ineffective or unsafe
for the subject.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To measure the time to failure (recurrence or progression of disease) in patients with esophageal cancer treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.
Susan Urba, M.D.
University of Michigan Cancer Center
United States: Food and Drug Administration
|University of Michigan Cancer Center||Ann Arbor, Michigan 48109|