Octreotide in Treating Patients With Cancer-Related Malignant Ascites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182754
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: octreotide acetate Other: placebo Phase 3

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients
Study Start Date : October 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I
Patients receive octreotide subcutaneously (SC) once on day 1.
Drug: octreotide acetate
Given subcutaneously
Placebo Comparator: Arm II
Patients receive placebo SC once on day 1.
Other: placebo
Given subcutaneously

Primary Outcome Measures :
  1. Median Time to Paracentesis [ Time Frame: 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 :
  1. Number of Paracenteses [ Time Frame: Up to 2 years ]
    We will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.

  2. Average Quality-of-life [ Time Frame: 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';

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed cancer
  • Diagnosis of malignant ascites, as determined by the treating oncologist

    • Positive cytology not required
    • Patient is symptomatic and views ascites as a problem
  • No lymphoma or lymphomatous ascites
  • Planning therapeutic paracentesis ≤ 3 days after study entry OR completed therapeutic paracentesis 2 days before study entry



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 4 weeks


  • Not at high risk of bleeding from a procedure


  • No known cirrhosis or portal hypertension


  • No known history of chronic renal failure, defined as creatinine ≥ 2 times upper limit of normal


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Prior cholecystitis allowed provided patient underwent cholecystectomy
  • No uncontrolled diabetes mellitus
  • No known allergy to octreotide
  • No known allergy to latex
  • No medical condition that would preclude study treatment


Biologic therapy

  • No concurrent bevacizumab


  • No concurrent intraperitoneal chemotherapy
  • No concurrent first-line chemotherapy for any cancer except pancreatic cancer

    • Concurrent second-line chemotherapy or later-line chemotherapy allowed

Endocrine therapy

  • No other concurrent octreotide


  • Not specified


  • Not specified


  • No concurrent therapeutic warfarin

    • Concurrent prophylactic warfarin at a dose of 1 mg/day allowed
  • No other concurrent treatment for ascites except paracentesis or ongoing diuretics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00182754

  Show 122 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Aminah Jatoi, MD Mayo Clinic

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00182754     History of Changes
Other Study ID Numbers: NCCTG-N04C2
NCI-2009-00647 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000440922 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 16, 2005    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: February 2017

Keywords provided by Alliance for Clinical Trials in Oncology:
unspecified adult solid tumor, protocol specific
malignant ascites

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents