Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Octreotide in Treating Patients With Cancer-Related Malignant Ascites

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI NCCTG-N04C2 NCT00182754

Special Category: NCI Web site featured trial

Objectives

Primary

1. Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites.

Secondary

1. Compare the number of paracenteses in patients treated with these drugs.
2. Determine the toxicity of octreotide in these patients.
3. Compare the quality of life of patients treated with these drugs.

Entry 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

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

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

Expected Enrollment

A total of 68 patients (34 per treatment arm) will be accrued for this study.

Outcomes

Median time to paracentesis

VEGF concentrations in ascitic fluid
Number of paracenteses
Toxicity incidence
Average quality-of-life

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Paul Schaefer, MD, Protocol co-chair		Ph: 419-479-5605
Lynn Hartmann, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Karin Giordano, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

U.S.A.
Colorado
	Aurora
	Aurora Presbyterian Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	Boulder
	Boulder Community Hospital
		Clinical Trials Office - Boulder Community Hospital	Ph:  303-938-5253
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph:  719-776-5275
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo Pajon, MD	Ph:  303-777-2663
	Porter Adventist Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	Presbyterian - St. Luke's Medical Center
		Clinical Trials Office - Presbyterian - St. Luke's Medical Center	Ph:  303-839-6000
	Rose Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	St. Anthony Central Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	St. Joseph Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	Englewood
	Swedish Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Grand Junction
	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Greeley
	North Colorado Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Lone Tree
	Sky Ridge Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	Loveland
	McKee Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Thornton
	North Suburban Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Wheat Ridge
	Exempla Lutheran Medical Center
		Clinical Trials Office - Exempla Lutheran Medical Center	Ph:  303-403-3605
Illinois
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith Rowland, MD	Ph:  217-383-3010
	Effingham
	St. Anthony's Memorial Hospital
		Clinical Trials Office - St. Anthony's Memorial Hospital	Ph:  217-347-1305
	Joliet
	Joliet Oncology-Hematology Associates, Limited - West
		Kendrith Rowland, MD	Ph:  217-383-3010
	Moline
		Costas Constantinou, MD
		Costas Constantinou, MD	Ph:  916-734-2781
		Costas Constantinou, MD	Ph:  309-779-4265
		Costas Constantinou, MD	Ph:  309-779-5090
	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
		Costas Constantinou, MD	Ph:  309-779-5092
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		Clinical Trials Office - Carle Cancer Center	Ph:  800-446-5532
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Elkhart
	Elkhart General Hospital
		Robin Zon, MD	Ph:  574-294-2621
	Kokomo
	Howard Community Hospital
		Robin Zon, MD	Ph:  765-453-8571
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Robin Zon, MD	Ph:  219-326-2683
	Michigan City
	Saint Anthony Memorial Health Centers
		Kendrith Rowland, MD	Ph:  217-383-3010
	South Bend
	CCOP - Northern Indiana CR Consortium
		Robin Zon, MD	Ph:  574-647-7370 800-284-7370
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Robin Zon, MD	Ph:  574-237-7111
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Bettendorf
		Costas Constantinou, MD	Ph:  563-421-1960
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Des Moines
	CCOP - Iowa Oncology Research Association
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Mercy Capitol Hospital
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-9326
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-9326
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-9326
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Southwest Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center	Ph:  517-265-0116
	Lambertville
	Haematology-Oncology Associates of Ohio and Michigan, PC
		Paul Schaefer, MD	Ph:  419-843-6147
	Monroe
	Community Cancer Center of Monroe
		Paul Schaefer, MD	Ph:  419-843-6147
	Mercy Memorial Hospital - Monroe
		Paul Schaefer, MD	Ph:  419-843-6147
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Robin Zon, MD	Ph:  269-983-8698 800-303-8399
Minnesota
	Alexandria
		Harold Windschitl, MD	Ph:  320-762-8903 800-835-6624
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-8364
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-727-8762
	Fergus Falls
		Harold Windschitl, MD	Ph:  218-739-6654
		Harold Windschitl, MD	Ph:  800-237-1225
	Mankato
	Immanuel St. Joseph's
		Glenn Harman, MD	Ph:  507-625-4031 800-327-3721
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Cloud
	CentraCare Clinic - River Campus
		Harold Windschitl, MD	Ph:  320-252-5131
	Coborn Cancer Center
		Harold Windschitl, MD	Ph:  320-229-4907 877-229-4907
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-259-2245 800-361-3239
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290 800-648-6274
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-248-2212 800-358-8818
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-657-7000
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-585-5070
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-723-2500
	Great Falls
		Benjamin Marchello, MD
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-454-2171 800-421-1649
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-442-2480
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-752-7600
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-752-8900
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-752-5111
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-728-4100
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-721-1118
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center