Know Cancer

forgot password

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

Phase 3
18 Years
Open (Enrolling)
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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



- 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.

PROJECTED ACCRUAL: A total of 68 patients (34 per treatment arm) will be accrued for this

Inclusion Criteria


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Median time to paracentesis

Safety Issue:


Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • malignant ascites
  • Ascites
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
CCOP - Colorado Cancer Research Program Denver, Colorado  80224-2522
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
St. Mary - Corwin Regional Medical Center Pueblo, Colorado  81004
North Suburban Medical Center Thornton, Colorado  80229
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
MeritCare Bemidji Bemidji, Minnesota  56601
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Mercy Medical Center Toledo, Ohio  43608
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Southwest Medical Center Liberal, Kansas  67901
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
South Bend Clinic South Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Community Cancer Center of Monroe Monroe, Michigan  48162
Alexandria, Minnesota  56308
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Bismarck Cancer Center Bismarck, North Dakota  58501
Wood County Oncology Center Bowling Green, Ohio  43402
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Fulton County Health Center Wauseon, Ohio  43567
St. Anthony Central Hospital Denver, Colorado  80204-1335
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Billings Clinic - Downtown Billings, Montana  59107-7000
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
North Coast Cancer Care - Clyde Clyde, Ohio  43410
Hematology Oncology Center Elyria, Ohio  44035
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Immanuel St. Joseph's Mankato, Minnesota  56002