Outlook: Clinical Trials

JULY 01, 2008
Susan Farley

Ms. Farley is a freelance medical writer based in Wakefield, Rhode Island.

Hope for Patients with Pancreatic Cancer

The survival rate for patients with pancreatic cancer could possibly double when gemcitabine (Gemzar) is used after surgery, according to a recent study. Pancreatic cancer is considered one of the deadliest cancers, offering patients a dire prognosis— made worse by the fact that it is often not diagnosed until it is too late for effective treatment. The downside of gemcitabine's postsurgery efficacy is that only about 15% of patients with pancreatic cancer are surgical candidates. Currently, gemcitabine is the standard treatment when pancreatic cancer cannot be surgically removed.


Survival Without Recurrence

Overall Survival


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5-year Mark

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Researchers expect widespread adoption of gemcitabine in the treatment of postsurgery pancreatic cancer. Study results were presented at the American Society of Clinical Oncology's annual meeting in Chicago this past May.

Chemo Drug Equals Effectiveness of Radiation

The most common cancer in men aged 15 to 45 is testicular cancer, with the standard treatment being surgery followed by radiation. A recent study, however, has shown that a single dose of the chemotherapy drug carboplatin is just as effective as radiation therapy but not as toxic. A randomized study included 573 patients who received a single dose of carboplatin dosed over 1 hour on an outpatient basis and 904 patients who received daily radiotherapy over a 2- to 3-week period. The 5-year mark showed similar cancer recurrence rates in both groups: 5% in the carboplatin group and 4% in the radiation group.

Test Pinpoints Who Benefits from Cancer Drug

Study results presented at the May American Society of Clinical Oncology annual meeting reveal that, with colon cancer, physicians can now determine which patients will benefit from the chemotherapy drug cetuximab (Erbitux). By using a KRAS test, clinicians can pinpoint which patients have the normal version of a particular gene and know that those patients will benefit from treatment with cetuximab, which has been approved as an addition to chemotherapy—but only for patients with the normal version of the gene. Researchers reviewed tumor samples from 587 patients and found that those with normal KRAS genes had a 32% reduced risk of cancer recurrence, compared with 15% for all patients. Knowing who should receive the drug beforehand may indicate the future of cancer treatment—tailored or personalized therapy for patients.

Erbitux Offers Small Hope in Lung Cancer Battle

Researchers have found that the cancer drug cetuximab (Erbitux), when combined with chemotherapy, extends the life of patients with advanced non? small-cell lung cancer (NSCLC) by about 5 weeks. In the lung cancer arena, it is important to note that prognosis is still very poor, and the 5-year survival rate is less than 5%. In fact, other clinical trials have shown cetuximab to have no benefits, and this trial is only the second one to show any positive results. Cetuximab acts like bevacizumab (Avastin) by cutting off a tumor's blood supply. Bevacizumab, it should be noted, is the only approved targeted therapy for NSCLC. The study that yielded these results included 1125 patients with stage IV cancer randomized to platinum-based chemotherapy alone or chemotherapy plus cetuximab. The cetuximab group lived 11.3 months on average, compared with 10.1 months in the chemotherapy-only group.

Cancer Pain Drug May Reduce Intensity

Phase 3 trials have been completed for BEMA Fentanyl in the treatment of "breakthrough pain" (BTP) in cancer patients who can tolerate opioids. The drug is a small, dissolvable film containing fentanyl that is applied to the inner lining of the cheek membranes. In the study, 81 patients received BEMA Fentanyl and placebo in a random order to treat their BTP episodes. Altogether, 394 BTP episodes were treated with BEMA Fentanyl, and 197 were treated with placebo. The end point was to determine the sum of pain intensity difference at 30 minutes; the difference in pain intensity was significantly (and positively) higher when the patient took BEMA Fentanyl. The long-term study included 220 patients and more than 56,000 BTP episodes. The average dosage was 2.9/day for 112 days.

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Manufacturers are awaiting an August 2008 decision on their new drug application.