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June 2008 Issue

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Medication Might Offset Chemo Side Effects

By Amanda Harper
Published June 2008

The side effects of cancer therapy can be difficult to handle—especially with a heavy chemotherapy regimen that causes damage to other cells in its quest to eradicate rogue cancer cells.

That’s why UC physician-scientist Malek Safa, MD, is leading a phase-2 clinical trial for colorectal cancer patients to help reduce one of the most serious side effects of chemotherapy—neuropathy.

“Up to 20 percent of colorectal cancer patients who receive oxaliplatin-based chemotherapy experience significant neuropathy that impacts their daily lives,” explains Safa, associate professor of clinical medicine at UC and medical oncologist with the UC Barrett Cancer Center at University Hospital.

The most common neuropathy symptom patients report is tingling in the fingertips and toes. Although this may seem like a nuisance at first, Safa says the condition can quickly become a serious problem.

“Neuropathy can eventually affect the person’s functional abilities—for example, the person may not be able to grasp objects or button shirts,” Safa explains. “This can greatly impact his or her quality of life.”

Safa will test whether amifostine (A-mi-FOS-teen) can reduce neuropathy when given prior to chemotherapy.

Amifostine is in a class of drugs known as “chemoprotectants” that have been shown to shield non-cancerous cells from the harmful effects of cancer treatment. Previous studies have shown that amifostine, which is given by injection, specifically protects nerve cells from radiation and the effects of chemotherapy drugs like cisplatin.

It is approved by the U.S. Food and Drug Administration to prevent moderate or severe dryness of the mouth caused by radiation treatment for head and neck cancer and to prevent kidney damage caused by cisplatin chemotherapy in ovarian and non small-cell lung cancer patients.

“Although amifostine may not prevent this neuropathy entirely,” Safa adds, “it may prevent the condition from worsening, allowing the patient to safely stay on oxaliplatin for a longer period without further side effects.”

This UC investigator-initiated clinical trial is looking for about
28 patients with stage-2, 3 or 4 colorectal cancer who are candidates to receive oxaliplatin-based chemotherapy.

Study participants will receive a standard chemotherapy drug regimen known as FOLFOX, which consists of three intravenous drugs—5-FU, leucovorin and oxaliplatin—and another drug, Avastin, if recommended by the doctor. Amifostine will be given about an hour prior to each chemotherapy session to prevent nerve damage.

All medications will be given intravenously every two weeks
for six months. Each treatment will last 1 to 1.5 hours and can be administered at most UC-affiliated clinics. Response to the drugs will be monitored using regular blood tests and physical examinations that may include imaging tests.

According to the American Cancer Society, more than 148,000 Americans will be diagnosed with colorectal cancer in 2008.

For more information on study eligibility, call (513) 584-7614.
Safa has no financial interest in MedImmune Oncology, partial sponsor of the study. 


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