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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase III Randomized Study of Octreotide in Patients With Cancer-Related Symptomatic Malignant Ascites

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	NCCTG-N04C2 NCT00182754

Special Category: NCI Web site featured trial

Trial Description

Purpose:

Octreotide may be an effective treatment for malignant ascites. It is not yet known whether octreotide is more effective than a placebo in treating malignant ascites.

This randomized phase III trial is studying octreotide to see how well it works compared to placebo in treating patients with cancer -related malignant ascites.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No lymphoma
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive an injection of octreotide once in week 1. They will then receive an injection of octreotide once a month for up to 2 years.

Patients in group two will receive an injection of placebo once in week 1. They will then receive an injection of placebo once a month for up to 2 years.

Quality of life will be assessed at the beginning of treatment, at 2 weeks, and once a month during treatment. After finishing treatment, patients will be evaluated every 6 months for up to 2 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Paul Schaefer, MD, Protocol co-chair		Ph: 419-479-5605
Lynn Hartmann, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Karin Giordano, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Related Information

Featured trial article

Registry Information
Official Title		An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LAR® Depot) for Symptomatic Ascites in Cancer Patients
Trial Start Date		2005-10-28
Registered in ClinicalTrials.gov		NCT00182754
Date Submitted to PDQ		2005-12-07
Information Last Verified		2009-08-07

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