Octreotide in Treating Patients With Cancer-Related Malignant Ascites

Phase 3

Completed

Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm I	octreotide acetate	Patients receive octreotide subcutaneously (SC) once on day 1.
Arm II	placebo	Patients receive placebo SC once on day 1.

Primary Outcome Measures

Name	Time	Method
Median Time to Paracentesis	Up to 2 years	Kaplan Meier curves will be constructed for each group; patients lost to follow up will be censored. A log rank test will be used to compare groups. We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.

Secondary Outcome Measures

Name	Time	Method
Average Quality-of-life	Up to 2 years	Quality of life will be recorded and analyzed in a descriptive, exploratory fashion. We acknowledge that this study will represent the first to attempt a prospective assessment of quality of life in patients with symptomatic ascites. The underlying hypothesis of this quality of life assessment is that patients who are receiving octreotide will enjoy a better quality of life compared to patients who receive placebo. Quality of life scores from the CLDQ will be summed for all patients on a monthly basis. Again we anticipate high patient drop out rates over time within these two cohorts. With due diligence, we will attempt to ascertain the reason for each patient drop out, and appropriate imputation techniques will be employed for each.Quantified as: 1='All of the time' 2='Most of the time' 3='A good bit of the time' 4='Some of the time' 5='A little bit of the time' 6='Hardly any of the time' 7='None of the time' 0='Missing';
Number of Paracenteses	Up to 2 years	We will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.

Locations (117): Aurora Presbyterian Hospital
🇺🇸
Aurora, Colorado, United States
Boulder Community Hospital
🇺🇸
Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸
Colorado Springs, Colorado, United States
St. Anthony Central Hospital
🇺🇸
Denver, Colorado, United States
Porter Adventist Hospital
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Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
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Denver, Colorado, United States
St. Joseph Hospital
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Denver, Colorado, United States
Rose Medical Center
🇺🇸
Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
🇺🇸
Denver, Colorado, United States
Swedish Medical Center
🇺🇸
Englewood, Colorado, United States
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Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States