Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Endocrinology | Oncology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Pharmacia & Upjohn
Approval Status: Approved June 1996
Treatment Area: metastatic colorectal cancer
Camptosar Injection has been approved for the treatment of
metastatic colorectal cancer that has recurred or progressed after
standard therapy with the anticancer agent fluorouracil.
The most consistent responses were observed in subjects
beginning treatment at the recommended 125 mg/m2 starting dose. Of
the 193 subjects treated at this dose level, 29 experienced a
positive response for an overall response rate of 15%. Response
refers to the complete disappearance of a tumor (two of the 29
subjects) or a reduction of its size by at least 50% (27 of the 29
Camptosar has been associated with severe diarrhea and severe
myelosuppression (a reduction of white blood cells, which could
increase risk of infection). Other side effects of medical
importance are nausea and vomiting. Aggressive administration of
loperamide reduced the incidence of serious diarrhea.
Colorectal cancer is the third leading cancer killer of U.S. men
(after lung cancer and prostate cancer). It is the third leading
cancer killer of U.S. women (after lung cancer and breast cancer).
It is the second leading cancer killer of U.S. men and women
combined (after lung cancer).
Each year colorectal cancer is diagnosed in about 133,500 people
in the United States. In half of these cases, the disease has
spread from the colon or rectum to other parts of the body
(metastasized). The standard drug treatment for subjects with
metastatic colorectal cancer is fluorouracil (5-FU). About 20% of
the people who receive this medicine respond favorably. However, in
all of these cases, the cancer will eventually progress.