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Name of the Trial

Phase III Randomized Study of Octreotide in Patients With Cancer-Related Symptomatic Malignant Ascites (NCCTG-N04C2). See the protocol summary ³.

Principal Investigator

Dr. Aminah Jatoi, North Central Cancer Treatment Group.

Why This Trial Is Important

Dr. Aminah Jatoi Principal Investigator

Malignant ascites is an abnormal build-up 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 two 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 ⁴.

Study Sites and Contact Information

Study sites in the United States are recruiting patients for this trial. See the list of study contacts ⁵ 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.

Glossary Terms

The area of the body that contains the pancreas, stomach, intestines, liver, gallbladder, and other organs.

A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin).

Research done in a laboratory. These studies may use test tubes or animals to find out if a drug, procedure, or treatment is likely to be useful. Laboratory studies take place before any testing is done in humans.

The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.