Foundation for
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The Foundation for Applied Research in Gastrointestinal Oncology (FARGO) is
a non-profit 501 (c)(3) organization that promotes research, education and patient care in
gastrointestinal oncology. FARGO's primary objective is to facilitate the transfer of
basic science research into innovations in patient care. The responsibilities of FARGO
include financial support, administrative support, and space for continued progress in the
prevention and treatment of gastrointestinal cancer.
FARGO was created in 1993 by Dr. Paul Sugarbaker and the FARGO Board of Directors. Current
FARGO staff include:
Paul Sugarbaker, M.D. Dal Yoo, M.D. Gerald Parker, M.D. Neil Otchin, M.D. Joy Midman Peter Lipresti, Esq. Donald Farren, CPA |
President Vice President Member, Board of Directors Member, Board of Directors Member, Board of Directors Legal Counsel Accountant |
A major goal of FARGO is the transfer of basic science research into improvements
in patient care. The primary means to accomplish this transfer of information is the
publication and presentation of research. FARGO supported in-part 53 publications in 1997.
There were 9 exhibits and poster presentations and 12 speaking engagements by persons
sponsored by FARGO.
A Message From the President of FARGO
On a daily basis, we hear about "basic science breakthroughs"
that the press implies will soon benefit patients with cancer. Yet, the months and years
go by with little or no progress in digestive tract cancer management. Few clinicians
recognize that these malignancies have a unique anatomic location that gives them a
special natural history and provides a rationale for local-regional therapy. Our strategy
in gastrointestinal cancer research (stomach, pancreas, and large bowel cancer) is to
eliminate the last cancer cell by combinations of surgery and regional chemotherapy.
Revisions in the techniques by which primary cancer is resected promises to minimize the
incidence of abdominal and pelvic recurrences. Regional chemotherapy now being tested in
phase III trials should further reduce the portion of patients having "surgical
treatment failures". Also, a small portion of patients with established peritoneal
surface disease can be rescued long-term through the use of aggressive surgery and
intraperitoneal chemotherapy. Clinical and laboratory research supervised and funded by
FARGO have improved the survival of patients with gastrointestinal cancers treated at The
Washington Cancer Institute/Washington Hospital Center. Many small changes in the way
these cancers are approached have resulted in great differences in the lives of these
patients. Pseudomyxoma peritonei, peritoneal mesothelioma, small volume peritoneal surface
spread of colon cancer, and limited sarcomatosis have now been recognized around the world
as reasonable options for these treatments. FARGOs goal is not only to continue this
productivity, but also to expand these treatment options to other institutions in other
countries.
Our Mission
The Foundation for Applied Research in Gastrointestinal Oncology (FARGO)
is a non-profit 501 (c)(3) organization that is intended to promote research, education,
and patient care in gastrointestinal cancer. FARGOs outreach is world wide. The
Foundations major goal is to implement the transfer of basic science research to
innovations in patient care. The responsibilities of FARGO are to provide financial
support, administrative support, and space for continued progress in the prevention and
treatment of gastrointestinal cancer.
Current Research Projects
FARGO supports financially and intellectually a wide variety of research
projects in gastrointestinal oncology. The following is a report of current research
projects.
Heated Intraoperative Intraperitoneal Chemotherapy (HIIC)
Using the Coliseum Technique
The investigational phase of hyperthermic intraoperative intraperitoneal chemotherapy with mitomycin C was completed after 60 patients were enrolled in our IRB approved study. This is now the standard of care for patients with demonstrated peritoneal surface spread of appendiceal cancer, pseudomyxoma peritonei, colonic cancer with limited peritoneal carcinomatosis, and some patients with recurrent peritoneal carcinomatosis from ovarian malignancy. Pharmacokinetics were measured on the first 18 patients who had the "closed abdomen technique" and the first 10 patients who had the "coliseum technique". To date, a total of 295 patients have been treated with mitomycin C. There is a spectacular pharmacologic advantage with the intraperitoneal delivery of chemotherapy as compared to its intravenous use. Heat increases the cytotoxicity of the chemotherapy, increases drug penetration and, in some instances, may cause thermal cell kill. Currently, esophageal doppler monitoring is being used to optimize uniformly distributed heat and chemotherapy. Temperatures that were found toxic with the closed method, are safe when using the coliseum technique and esophageal doppler monitoring. The immense survival advantage seen with this "cytoreductive approach" comes from a comparison with previous published data from the Mayo Clinic. Phase II studies in heated intraoperative intraperitoneal chemotherapy are continuing on a daily basis.
A study of hyperthermic intraperitoneal cisplatin enrolled 49 patients. The first 20 patients signed an informed consent in an IRB approved protocol. The histologies in this study included recurrent abdominopelvic sarcoma with sarcomatosis, peritoneal mesothelioma, and peritoneal carcinomatosis from recurrent ovarian cancer. Pharmacokinetics were measured in the first 19 patients. A dose escalation study with doxorubicin has brought us to a standardized treatment using the combined drugs. Currently, heated intraoperative intraperitoneal doxorubicin (15 mg/m2) and cisplatin (50 mg/m2) are being used in the operating room with esophageal doppler monitoring. The safe level of heat administration is currently being optimized.
The coliseum technique will be used in order to pursue other research
projects. Prolonged use of the coliseum (open abdomen technique for 5-7 days) will allow
us to use enzymes and chemotherapy in order to more completely debride mucinous tumor from
small bowel surfaces and other sites of residual disease. The possibility of a randomized
trial (mitomycin C plus heat versus heat alone) in pseudomyxoma peritonei patients with a
CC-1 cytoreduction is being considered. Another possible randomized study is to compare
heated mitomycin C to heated cisplatin and doxorubicin.
An adjuvant protocol for the treatment of pancreas cancer with surgery and heated
intraoperative intraperitoneal Gemcitabine is under development. Gemcitabine has produced
responses when given intravenously to pancreas cancer patients. We will attempt to utilize
this exciting new drug to eliminate microscopic residual disease after complete resection
of the pancreas malignancy.
External Hyperthermia with the RF-8 Thermotron.
This feasibility study has entered 26 patients. Our plans for this research project are as follows:
1. Publish experience with 200 cycles of external hyperthermia,
supplemented by mitomycin C.
2. Continue to find ways to optimize heat delivery (multiple ports, EMLA Cream, narcotic
premeditation, intravenous fluid administration, profound environmental cooling). We have
begun the entrance of patients with unresectable liposarcomas into the study. New drugs
will eventually be incorporated into the protocol (doxol and CPT-11).
3. Initiate treatment of Grade I abdominal and pelvic sarcomas.
In-vitro Tumor Marker Analysis
This study will determine the effectiveness of monitoring CA 15-3, CA 19-9, CA 72-4,
CA-125 and CEA as an indication of tumor recurrence or efficacy of therapy. The trends and
levels of these tumor markers will be compared to conventional techniques of monitoring
patients in an attempt to find a reliable and lower cost method of surviellance after
surgery.
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