An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients
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.
PROJECTED ACCRUAL: A total of 68 patients (34 per treatment arm) will be accrued for this
study.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Median time to paracentesis
Safety Issue:
No
Principal Investigator
Aminah Jatoi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000440922
NCT ID:
NCT00182754
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
Name | Location |
|---|---|
| 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 |
