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Octreotide in Treating Patien...

Octreotide in Treating Patients With Cancer-Related Malignant Ascites

Last Updated: 2017-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I

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

Group Type EXPERIMENTAL

octreotide acetate

Intervention Type DRUG

Given subcutaneously

Arm II

Patients receive placebo SC once on day 1.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given subcutaneously

Interventions

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octreotide acetate

Given subcutaneously

Intervention Type DRUG

placebo

Given subcutaneously

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aminah Jatoi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Moline, Illinois, United States

Site Status

Moline, Illinois, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Saint Joseph Regional Medical Center

South Bend, Indiana, United States

Site Status

South Bend Clinic

South Bend, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Bettendorf, Iowa, United States

Site Status