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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Octreotide in Treating Patients With Cancer-Related Malignant Ascites

NCTNCT00182754 (opens ClinicalTrials.gov in a new tab)Other idNCCTG-N04C2Other idNCI-2009-00647Other idCDR0000440922
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Overview

Status
Completed
Phase
Phase 3
Enrollment
33 participants (actual)
Sponsor
Alliance for Clinical Trials in Oncology · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Oct 2005
Primary completion
Sept 2009
Completion
Mar 2013
First posted
16 Sept 2005 (estimated)
Last update posted
11 Apr 2017
Conditions
Metastatic Cancer · Unspecified Adult Solid Tumor, Protocol Specific

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062008201020122014
  1. Ph 3

    Octreotide in Treating Patients With Cancer-Related Malignant Ascites

    NCT00182754

    Oct 2005 to Mar 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • octreotide acetateDrug
  • placeboOther

Arms2

  • Experimental

    Arm I

    Patients receive octreotide subcutaneously (SC) once on day 1.

  • Placebo comparator

    Arm II

    Patients receive placebo SC once on day 1.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Median Time to Paracentesis

    Time frame · Up to 2 years

    Registry description

    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 We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.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 outcomes(2)

  1. Number of Paracenteses

    Time frame · Up to 2 years

    Registry description

    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

    Registry description

    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';

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Up to 2 years

Median Time to Paracentesis

GroupValue (days)
Arm I28
Arm II14
Secondary and other outcome results(2)
Secondary outcomeMedian· Up to 2 years

Number of Paracenteses

GroupValue (number of paracenteses per patient)
Arm I0.5
Arm II1
Secondary outcomeMedian· Up to 2 years

Average Quality-of-life

GroupValue (QOL score)
Arm I4
Arm II3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Arm IPatients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously–1 / 1616 / 16
Arm IIPatients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously–0 / 1716 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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