Featured Research

from universities, journals, and other organizations

Clinical Trial Of Gefitinib For Advanced Lung Cancer Closes Early

Date:
April 19, 2005
Source:
NIH/National Cancer Institute
Summary:
Researchers have closed a randomized clinical trial comparing gefitinib (IressaTM) vs. placebo following chemotherapy and radiation for patients with non-small cell lung cancer (NSCLC) that had spread only to nearby tissues or lymph nodes.

Researchers have closed a randomized clinical trial comparing gefitinib (IressaTM) vs. placebo following chemotherapy and radiation for patients with non-small cell lung cancer (NSCLC) that had spread only to nearby tissues or lymph nodes. Review of interim data indicated that gefitinib would not improve survival.

The clinical trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health in Bethesda, Md., and was conducted by a network of researchers led by the Southwest Oncology Group (SWOG), Ann Arbor, Mich. AstraZeneca Pharmaceuticals LP, Wilmington, Del., which manufactures gefitinib, provided the agent for the trial under the Clinical Trials Agreement with NCI for the development of gefitinib. Iressa is a drug that inhibits an enzyme (tyrosine kinase) present in lung cancer cells, as well as other cancers and normal tissues, that appears to be important to the growth of cancer cells.

Based on a review of the limited data available from the Phase III clinical trial, the Data Monitoring Committee overseeing the trial (known as S0023*) recommended the closure, as the trial would not meet its primary endpoint of improved survival. Detailed results from the study will be presented at the American Society of Clinical Oncology Annual Meeting (ASCO) on May 14, 2005.

The study was designed to assess whether maintenance therapy with gefitinib -- gefitinib given to help keep cancer in control -- would improve overall survival and progression-free survival as compared to placebo in patients with stable or responding disease. These patients had inoperable stage III NSCLC and already had completed the combined chemotherapy regimen of cisplatin and etoposide with radiation, followed by docetaxel. A total of 672 patients in this study were to be randomized to one of two treatment arms following chemotherapy and radiation: one arm would receive gefitinib daily and the other arm would receive a placebo daily. As of March 10, 2005, 611 patients were entered and 276 were randomized to one of the two arms.

"The interim analysis indicates that even with accrual of more patients or with longer follow-up, the gefitinib arm would not improve survival," said Laurence Baker, D.O., chairman of SWOG and professor of internal medicine and pharmacology at the University of Michigan in Ann Arbor. This analysis did confirm, however, the favorable survival seen with the chemotherapy and radiation regimen previously reported by SWOG**, and thus patients currently entered in the trial are being advised to complete this part of their treatment.

"Based on the analysis, the use of gefitinib following chemotherapy and radiation should not be prescribed for this group of patients," said Scott Saxman, M.D., who oversees lung cancer clinical trials for NCI.

An estimated 172,570 people will be diagnosed with lung cancer in the United States in 2005. Lung cancer is the second most commonly diagnosed cancer and the leading cause of cancer-related death in both men and women in this country. An estimated 163,510 deaths from lung cancer will occur in 2005 in the United States, accounting for about 29 percent of all cancer-related deaths in the nation.

###

For more information about cancer, visit the NCI Web site at http://www.cancer.gov or call NCI's Cancer Information Service at 1-800-4 CANCER (1-800-422-6237).

*S0023 A Phase III Trial of Cisplatin/Etoposide/Radiotherapy with Consolidation Docetaxel Followed by Maintenance Therapy with ZD 1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer.

** Gandara DR, Chansky K, Albain KS, Leigh BR, Gaspar LE, Lara PN Jr, Burris H, Gumerlock P, Kuebler JP, Bearden JD, Crowley J, Livingston R. Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIB non-small-cell lung cancer: phase II Southwest Oncology Group study S9504. J Clin Oncol 21(10):2004-2010, 2003.


Story Source:

The above story is based on materials provided by NIH/National Cancer Institute. Note: Materials may be edited for content and length.


Cite This Page:

NIH/National Cancer Institute. "Clinical Trial Of Gefitinib For Advanced Lung Cancer Closes Early." ScienceDaily. ScienceDaily, 19 April 2005. <www.sciencedaily.com/releases/2005/04/050419094503.htm>.
NIH/National Cancer Institute. (2005, April 19). Clinical Trial Of Gefitinib For Advanced Lung Cancer Closes Early. ScienceDaily. Retrieved July 28, 2014 from www.sciencedaily.com/releases/2005/04/050419094503.htm
NIH/National Cancer Institute. "Clinical Trial Of Gefitinib For Advanced Lung Cancer Closes Early." ScienceDaily. www.sciencedaily.com/releases/2005/04/050419094503.htm (accessed July 28, 2014).

Share This




More Health & Medicine News

Monday, July 28, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Trees Could Save More Than 850 Lives Each Year

Trees Could Save More Than 850 Lives Each Year

Newsy (July 27, 2014) A national study conducted by the USDA Forest Service found that trees collectively save more than 850 lives on an annual basis. Video provided by Newsy
Powered by NewsLook.com
Google's Next Frontier: The Human Body

Google's Next Frontier: The Human Body

Newsy (July 27, 2014) Google is collecting genetic and molecular information to paint a picture of the perfectly healthy human. Video provided by Newsy
Powered by NewsLook.com
What's To Blame For Worst Ebola Outbreak In History?

What's To Blame For Worst Ebola Outbreak In History?

Newsy (July 27, 2014) A U.S. doctor has tested positive for the deadly Ebola virus, as the worst-ever outbreak continues to grow. Video provided by Newsy
Powered by NewsLook.com
Losing Sleep Leaves You Vulnerable To 'False Memories'

Losing Sleep Leaves You Vulnerable To 'False Memories'

Newsy (July 27, 2014) A new study shows sleep deprivation can make it harder for people to remember specific details of an event. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins