Octreotide in Treating Patients With Cancer-Related Malignant Ascites
Recruitment status was Active, not recruiting
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: octreotide acetate
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients|
- Median time to paracentesis [ Designated as safety issue: No ]
- VEGF concentrations in ascitic fluid [ Designated as safety issue: No ]
- Number of paracenteses [ Designated as safety issue: No ]
- Toxicity incidence [ Designated as safety issue: Yes ]
- Average quality-of-life [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
Experimental: Arm I
Patients receive octreotide subcutaneously (SC) once on day 1.
Drug: octreotide acetate
Placebo Comparator: Arm II
Patients receive placebo SC once on day 1.
- Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites.
- 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.
PROJECTED ACCRUAL: A total of 68 patients (34 per treatment arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182754
Show 122 Study Locations
|Study Chair:||Aminah Jatoi, MD||Mayo Clinic|
|Investigator:||Paul L. Schaefer, MD||Toledo Clinic, Incorporated - Main Clinic|
|Investigator:||Lynn C. Hartmann, MD||Mayo Clinic|
|Investigator:||Karin F. Giordano, MD||Mayo Clinic|