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Dispatches from: The Montefiore Post, The Marshfield Post

	DISPATCH FROM: THE MONTEFIORE POST

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Montefiore Medical Center is Lead Study Site in Clinical Trial for Colorectal Cancer
Montefiore Medical Center announces that it is the lead study site for the largest trial to date for evaluating a potential treatment (octreotide acetate) for severe, chemotherapy-induced diarrhea. The study is seeking to enroll cancer patients at approximately 600 participating institutions.

Approximately 500 patients with colorectal cancer and who currently are receiving the chemotherapeutic agent 5-fluorouracil (5-FU) as part of their treatment are being sought for the trial. The study is being coordinated by the Eastern Cooperative Oncology Group (ECOG) with participation from the Southwest Oncology Group (SWOG) at major cancer centers across the United States.

Severe and debilitating diarrhea is a common side effect of 5-FU, a chemotherapeutic agent used to treat advanced cancers of the colon, rectum, breast, stomach and pancreas. The extreme fluid and electrolyte loss that accompanies severe diarrhea is potentially life threatening. At present, only standard antidiarrheals, such as loperamide, have been available to treat this side effect, but they have not been sufficient to manage the severe diarrhea commonly associated with chemotherapy.

Cancers of the colon and rectum account for approximately 9% of all newly diagnosed cancers, with an estimated 131,200 new cases and 54,900 deaths expected in 1997. Treatment may include surgery, radiation or chemotherapy, which commonly involves 5-FU.

In this new trial, colorectal cancer patients who have been treated with 5-FU (either alone or in combination with leucovorin or other agents) and who have experienced severe diarrhea will be randomized to one of three arms of treatment. There is a low-dose octreotide acetate arm (150 mg three times a day); a high-dose octreotide acetate arm (1,500 mg three times a day), and a loperamide arm. Octreotide acetate will be administered by injection; loperamide will be given orally. Patients will receive treatment for diarrhea either at home or in the hospital, depending on the severity of their symptoms.

Octreotide acetate (Sandostatin^®) is currently indicated for control of diarrhea and flushing (sudden and extreme heat and redness, usually on the face, neck and chest) in patients with metastatic carcinoid tumors and vasoactive intestinal peptide-secreting tumors (VIPomas). It is also indicated for the treatment of acromegaly, an endocrine tumor that secretes excessive amounts of growth hormone. Octreotide acetate mimics the action of the naturally occurring hormone somatostatin.

	DISPATCH FROM: THE MARSHFIELD POST

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Clinical Trial Open to Examine Use of New Agent to Overcome Chemotherapy Resistance in Multiple Myeloma Patients
Marshfield Cancer Center, the lead investigation site for a National Cancer Institute-sponsored multicenter clinical trial, is seeking patients to participate in a study of a potential new treatment, PSC 833, to overcome chemotherapy resistance in relapsing or refractory multiple myeloma. The study is coordinated by the Eastern Cooperative Oncology Group (ECOG).

Some multiple myeloma patients develop a resistance—known as multidrug resistance (MDR)—to chemotherapy treatment. This resistance occurs because a mechanism within the cancer cells "pumps" out the cytoxic drugs, thereby preventing these drugs from reaching toxic levels and destroying the malignant cells. Each year, approximately 800,000 cancer patients worldwide are unable to receive the optimal benefit of chemotherapy treatment due to MDR, a phenomenon that contributes substantially to morbidity and mortality.

Researchers will evaluate whether this potential treatment, PSC 833, when administered in combination with standard VAD (vincristine, doxorubicin and dexamethasone) chemotherapy, can help reduce the incidence of MDR in patients with relapsing or refractory multiple myeloma. Study participants will be randomly selected for one of two treatments: VAD with PSC 833 or VAD alone. The response, overall survival and event-free survival of patients treated with PSC 833 and VAD will be compared with patients treated with VAD alone. In addition, subjective responses, as evaluated by a decrease in pain and improvement in anemia, are secondary objectives.

Previous studies have suggested that PSC 833 is effective as an inhibitor of MDR in patients with multiple myeloma, acute leukemia and other malignancies. It was also shown to be well tolerated.

	FOOTNOTES

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Patients interested in more information about this study should ask their physician if they are eligible to participate or call the National Cancer Institute at 1-800-4-CANCER. Physicians interested in information for registering patients should contact the ECOG Coordinating Center at: 617-632-3610.

Patients interested in participating should consult their physician and/or call the National Cancer Institute’s information line: 800-4-CANCER. Physicians interested in registering patients should contact the ECOG Coordinating Center at: 617-632-3610. All study participants must be at least 18 years of age with a diagnosis of measurable multiple myeloma.

Marshfield Cancer Center is a service of Marshfield Clinic and Saint Joseph’s Hospital, Marshfield, Wisconsin.

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