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Clinical Trial to Study MoAb 17-1A as An Adjuvant to Colon Cancer Therapy

Clinical Trial to Study MoAb 17-1A as An Adjuvant to Colon Cancer Therapy

NEW YORK--Patients with stage III colon cancer are being sought
for a clinical trial newly underway to determine whether the monoclonal
antibody (MoAb) 17-1A is an effective adjuvant in combination
with 5-fluorouracil (5-FU) plus levamisole, said Richard Pazdur,
MD, associate professor of medicine, M.D. Anderson Cancer Center.

Speaking at the 13th annual symposium of the Chemotherapy Foundation,
Dr. Pazdur described the new MoAb (Panorex, from Glaxo Wellcome)
as a murine form of the IgG-2a MoAb 17-1A, which recognizes a
cell-surface glycoprotein preferentially expressed in adenocar-cinomas.
The 17-1A antibody has been shown in vitro to mediate antibody-dependent
cell cytotoxicity and complement-mediated cytolysis.

MoAb 17-1A has been approved for single-agent adjuvant therapy
in Germany, where a clinical trial showed significant reductions
in disease recurrence and cancer-related deaths. The most common
adverse events were diarrhea, abdominal pain, and nausea and vomiting.

Other adverse events included fever, chills, malaise, dizziness,
fatigue, headache, hot flushes, increased sweating, and hair loss.
There were no toxicity-related hospitalizations and no therapy-related
deaths. There were five severe anaphylactoid reactions, possibly
due to human antimouse antigen (HAMA) response.

Dr. Pazdur said that the ongoing US trial is studying 17-1A in
combination with 5-FU plus levamisole, currently the most widely
used postoperative adjuvant therapy for stage III colon cancer.

Compared with surgery alone, 5-FU plus levamisole produces a 41%
reduction in the risk of recurrence and a 33% reduction in overall
mortality, Dr. Pazdur said. The rationale for adding the MoAb,
he explained, is the complementary action and nonadditive toxicity
profiles of the two therapies.

The trial expects to enroll 1,800 patients over an 18-month period.
Patients receive either 5-FU plus levamisole beginning 22 to 28
days postoperatively according to the schedule used in prior clinical
trials, or 5-FU/levamisole and 500 mg of 17-1A intravenously beginning
15 to 21 days postoperatively, followed by 100 mg doses every
4 weeks for 4 additional weeks. Based on previous trials, it is
hoped that the lower monthly doses will result in weaker HAMA
response.

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