• 9/9/2005
  • Houston, TX
  • staff
  • CancerWise (www.cancerwise.com)

Goal is to Predict, Prevent Return of Stage I, II Disease

Lung cancer is the number one cause of cancer-related deaths in the United States and worldwide, but a rising tide of research focused on increasing survival and preventing recurrence hopes to change that sobering statistic.

Armed with a five-year grant from the Department of Defense, M. D. Anderson is conducting a clinical trial to increase screening of lung cancer and head and neck cancer survivors, and to test adjuvant therapies that may keep cancer from coming back.

Long-time smokers with skin or lung cancer targeted

The two-part clinical trial is known as VITAL: Vanguard Investigations of Therapeutic Approaches to Lung Cancer. It focuses on current or former smokers who have completed treatment for Stage I or II non-small cell lung cancer or head and neck squamous cell cancer.

Trial participants must have:

Stage I/II lung or head and neck cancer
A smoking history of at least 20 years
Completed either of the following:
Surgery or radiation no less than six months earlier
Chemotherapy (adjuvant) no less than three months earlier
“We want to focus on this population of patients because they are at risk of developing recurrences and new primary cancers largely based on their high-risk profile including smoking history,” says the trial’s co-principal investigator Edward Kim, M.D., an assistant professor in M. D. Anderson’s Department of Thoracic/Head and Neck Medical Oncology.

Survival statistics emphasize the need for the trial

Even if patients with early stage non-small cell lung cancer are successfully treated, their chances of long-term survival remain slim. “The five-year survival rate among these ‘cured’ patients is between 40% and 70%,” Kim says. “That’s not very good. Six out of 10 of these patients will have died in five years.”

The goals of the study include:

Assessing the incidence of recurring tumors
Increasing the amount of lung cancer screening
Predicting risk in patients
The study involves intensive monitoring of participants, who undergo yearly CT scans, blood work and other tests every three months for the first year and then every six months afterward, to detect any new cancers that may occur.

Patients also undergo bronchoscopy, a diagnostic procedure in which a tube with a tiny camera on the end is inserted through the nose or mouth into the lungs. The procedure, which is conducted under anesthesia, provides a view of the airways and allows doctors to collect secretions and tissue specimens.

Second part of study involves use of four drugs

Participants then have the option of being randomized into one of four trials testing different drugs to decrease smoking-related abnormalities in the lungs.

“We’re currently testing celecoxib (Celebrex®), which is FDA-approved for precancerous colon conditions and is being investigated in other prevention trials,” Kim says. A trial of erlotinib (Tarceva™), currently approved for treating advanced or metastatic non-small cell lung cancer, will open soon. Two other agents will be identified at a future date.

Lung tissue samples collected during the Vanguard trial will be used to establish a tissue bank, which investigators will use to test biomarkers (biologic changes in genes or tissue that signify cancer progression). Kim and his colleagues then hope to design an assessment tool that can predict an individual’s risk of being diagnosed with lung cancer.

For more information about the trial, call (713) 745-2784, or (713) 792-6363.