Pre-Operative Chemoradiation Followed by Post-Operative Tetrathiomolybdate (TM) in Patients With Loco-Regional Esophageal Carcinoma (UMCC 2001-007)
18 Years
N/A
Both
Esophageal Carcinoma
Trial Information
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
dosing.
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.
Inclusion Criteria
Eligibility Requirements
1. Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus
or gastroesophageal junction
2. No prior treatment for the esophageal cancer allowed.
3. No prior thoracic or upper abdominal radiation.
4. Disease should be limited to the esophagus and regional lymph nodes. Regional lymph
nodes are described in Section 4.0. However, celiac node enlargement will be
acceptable for tumors of the distal esophagus, because they will be included in the
radiation field.
5. Disease must be able to be encompassed in a single radiation field.
6. No medical contraindication to surgery
7. All treatment is to be administered at the University of Michigan Medical Center.
8. Karnofsky Performance Status > 70 %.
9. Age range: 18 - 75 years old.
10. Adequate baseline hematopoetic function:
Platelet count equal to or greater than 100,000/mm3 Absolute granulocyte count equal
to or greater than 1500/mm3 Hematocrit equal to or greater than 29% (patients may be
transfused to this level)
11. Adequate baseline organ function :
Creatinine clearance >/= 60 mls/min Bilirubin equal to or less than 1.5 x upper
limits of normal AST/ALT equal to or less than 2.5 x upper limits of normal
12. Patients with any complaint of hearing loss should be evaluated with an audiogram.
The average pure tone average hearing loss from 500-2000Hz should not exceed 30 dB.
If it does, the patient should be warned that further hearing loss may be very
noticeable and permanent.
13. Prior malignancy is acceptable if the patient is considered to be cured. In most
cases this will mean a 5-year disease-free period. Contact the Principal
Investigator for any specific question regarding this requirement.
14. Patients with active infection, serious inter-current medical conditions are
ineligible, according to the judgment of the investigators.
15. Pregnant or lactating females are not eligible. Women of childbearing Potential must
be using contraception throughout the entire period of treatment.
16. Ability to give informed consent.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
8 years
Safety Issue:
No
Principal Investigator
Susan Urba, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
UMCC 2001-007
NCT ID:
NCT00176800
Start Date:
November 2001
Completion Date:
November 2015
Related Keywords:
- Esophageal Carcinoma
- Carcinoma
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| University of Michigan Cancer Center | Ann Arbor, Michigan 48109 |
