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Octreotide in Treating Patients With Cancer-Related Malignant Ascites

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00182754
First received: September 15, 2005
Last updated: February 28, 2017
Last verified: February 2017
  Purpose

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 Intervention Phase
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: octreotide acetate
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 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 We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.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:
  • 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.

  • 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';


Enrollment: 33
Study Start Date: October 2005
Study Completion Date: March 2013
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 4 weeks

Hematopoietic

  • Not at high risk of bleeding from a procedure

Hepatic

  • No known cirrhosis or portal hypertension

Renal

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent bevacizumab

Chemotherapy

  • 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

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182754

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

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov 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) )
Study First Received: September 15, 2005
Results First Received: February 28, 2017
Last Updated: February 28, 2017

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

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

ClinicalTrials.gov processed this record on May 23, 2017