Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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