Octreotide in Treating Patients With Cancer-Related Malignant Ascites

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182754
• Other study ID #: NCCTG-N04C2
• Secondary ID: NCI-2009-00647CD
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: August 12, 2016
• Start date: October 2005
• Est. completion date: March 2013

Study information

• Verified date: August 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2013
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• octreotide acetate
Given subcutaneously

Other:
• placebo
Given subcutaneously

Locations

Country	Name	City	State
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	McFarland Clinic, PC	Ames	Iowa
United States	Aurora Presbyterian Hospital	Aurora	Colorado
United States	MeritCare Bemidji	Bemidji	Minnesota
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota
United States	Boulder Community Hospital	Boulder	Colorado
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	St. James Healthcare Cancer Care	Butte	Montana
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	North Coast Cancer Care - Clyde	Clyde	Ohio
United States	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado
United States	CCOP - Colorado Cancer Research Program	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian - St. Luke's Medical Center	Denver	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	St. Anthony Central Hospital	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa
United States	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Mercy Capitol Hospital	Des Moines	Iowa
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	CCOP - Duluth	Duluth	Minnesota
United States	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota
United States	Miller - Dwan Medical Center	Duluth	Minnesota
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Hematology Oncology Center	Elyria	Ohio
United States	Swedish Medical Center	Englewood	Colorado
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	MeritCare Broadway	Fargo	North Dakota
United States	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Northern Montana Hospital	Havre	Montana
United States	St. Peter's Hospital	Helena	Montana
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology at KRMC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Howard Community Hospital	Kokomo	Indiana
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Southwest Medical Center	Liberal	Kansas
United States	Lima Memorial Hospital	Lima	Ohio
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado
United States	McKee Medical Center	Loveland	Colorado
United States	Immanuel St. Joseph's	Mankato	Minnesota
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Community Medical Center	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital - Monroe	Monroe	Michigan
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CentraCare Clinic - River Campus	Saint Cloud	Minnesota
United States	Coborn Cancer Center	Saint Cloud	Minnesota
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Medical X-Ray Center, PC	Sioux Falls	South Dakota
United States	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	South Bend Clinic	South Bend	Indiana
United States	Lakeland Regional Cancer Care Center - St. Joseph	St. Joseph	Michigan
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	North Suburban Medical Center	Thornton	Colorado
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Anne Mercy Hospital	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Fulton County Health Center	Wauseon	Ohio
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median time to paracentesis		Up to 2 years	No
Secondary	Number of paracenteses		Up to 2 years	No
Secondary	Average quality-of-life		Up to 2 years	No