NCT00182754

Octreotide in Treating Patients With Cancer-Related Malignant Ascites

An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: 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. PURPOSE: 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.

Detailed description

OBJECTIVES: Primary * Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites. Secondary * Compare the number of paracenteses in patients treated with these drugs. * Determine the toxicity of octreotide in these patients. * Compare the quality of life of patients treated with these drugs. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to anticipated ongoing chemotherapy (yes vs no), frequency of prior paracentesis (never vs other), and prior chemotherapy (never vs only first-line chemotherapy vs second-line chemotherapy vs other). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive octreotide subcutaneously (SC) once on day 1. * Arm II: Patients receive placebo SC once on day 1. In both arms, treatment with intramuscular octreotide or placebo repeats monthly for up to 2 years in the absence of unacceptable toxicity. Quality of life is assessed at baseline, 2 weeks, and then monthly for up to 2 years during study treatment. After completion of study treatment, patients are followed every 6 months for up to 2 years.

Conditions

• Metastatic Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	octreotide acetate	Given subcutaneously
OTHER	placebo	Given subcutaneously

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-09-01
• Completion: 2013-03-01
• First posted: 2005-09-16
• Last updated: 2017-04-11
• Results posted: 2017-04-11

Locations

122 sites across 1 country: United States