Name of the Trial
Phase III Randomized Study of Octreotide in Patients with Cancer-Related Symptomatic Malignant Ascites (NCCTG-N04C2). See the protocol summary at http://cancer.gov/clinicaltrials/NCCTG-N04C2.

Principal Investigator
Dr. Aminah Jatoi, North Central Cancer Treatment Group

Why This Trial Is Important
Malignant ascites is an abnormal buildup of fluid in the abdomen caused by cancer. Ascites can cause discomfort, pain, problems with mobility and breathing, and other symptoms that decrease the quality of life for affected patients.

Paracentesis, the use of a thin needle or tube to remove excess fluid from the abdomen, can provide temporary relief from ascites. However, this and most other methods for treating ascites are invasive and uncomfortable for patients.

Octreotide, a drug similar to a naturally occurring growth-hormone inhibitor called somatostatin, decreases the secretion of fluid by the intestines and increases water reabsorption. Laboratory studies and case reports have indicated that octreotide may be effective in controlling malignant ascites, but the drug has not been tested in a randomized trial.

This trial will randomly assign patients with malignant ascites to receive a shot of either octreotide or a placebo once a month for up to 2 years. The investigators will see whether octreotide can delay the time until paracentesis is necessary or even whether the need for the paracentesis can be eliminated. They will also compare side effects and quality of life between the two groups.

"Ascites is a terrible problem for patients, and we often have to resort to invasive procedures to help them," explained Dr. Jatoi. "If there were some way we could help patients with this problem and not put them through invasive procedures every couple of weeks, that would be a really good thing."

Who Can Join This Trial
Researchers will enroll 68 cancer patients aged 18 or over diagnosed with malignant ascites. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/NCCTG-N04C2.

Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://www.cancer.gov/clinicaltrials/NCCTG-N04C2, or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.