Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075868

Purpose

RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea.

PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.

Condition	Intervention	Phase
Anal Cancer Colorectal Cancer Drug/Agent Toxicity by Tissue/Organ Radiation Enteritis	Drug: octreotide acetate	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	A Randomized, Double Blind, Placebo-Controlled Phase III Study To Determine The Efficacy Of Sandostatin LAR® Depot (Octreotide Acetate) In Preventing Or Reducing The Severity Of Chemoradiation-Induced Diarrhea In Patients With Anal Or Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Anal Cancer Cancer Colorectal Cancer Diarrhea

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Prevention of the incidence of moderate, severe, or life-threatening diarrhea

Secondary Outcome Measures:

Quality of life
Economic measures
Validity of the Functional Alterations due to Changes in Elimination-Changes in Bowel Function, the Quality of Life-Radiation Therapy Instrument, and the Expand Prostate Index Composite-Bowel questionnaires
Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea

Study Start Date:

December 2003

Detailed Description:

OBJECTIVES:

Primary

Determine the ability of octreotide to prevent the incidence of moderate, severe, or life-threatening chemoradiotherapy-induced diarrhea (grades 2-4) in patients with anal or rectal cancer.

Secondary

Compare the quality of life of patients treated with this drug vs placebo.
Compare the number of hospitalizations and use of antidiarrheal agents (e.g., Imodium®) related to diarrhea (or its complications) in patients treated with these drugs.
Compare treatment delays and/or dose reductions (chemotherapy and radiotherapy) in patients treated with these drugs.

OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to radiotherapy dose (< 50 Gy vs ≥ 50 Gy), chemotherapy dose (bolus vs continuous), and gender. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive octreotide* intramuscularly (IM) 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.
Arm II: Patients receive placebo* IM 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.

NOTE: *Patients receive a total of 2 injections of octreotide or placebo

In both arms, treatment continues in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, at the completion of chemoradiotherapy, and at 3, 6, 9, and 15 months from the start of chemoradiotherapy.

Patients are followed at 3, 6, 9, and 15 months from the start of chemoradiotherapy.

PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary anal or rectal cancer
- No metastasis beyond the pelvic regional nodes
Must be scheduled to receive chemoradiotherapy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Liver function tests < 3 times upper limit of normal
No prior hepatic disease

Renal

Not specified

Gastrointestinal

No prior chronic or acute regional enteritis
No malabsorption syndrome
No prior inflammatory bowel disease that may exacerbate the radiotherapy toxicity
No grade 2 or greater uncontrollable diarrhea at baseline
No prior cholecystitis or gallstones, unless a cholecystectomy has been performed
No prior incontinence of stool

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No uncontrolled diabetes (e.g., fasting glucose > 250 mg/dL)
No prior allergy or hypersensitivity to study drug or other related drug or compound
No other medical condition or mental impairment that would preclude study treatment and compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
Prior chemotherapy allowed

Endocrine therapy

At least 6 months since prior administration of any of the following:
- Glucocorticoid therapy
- Insulin sensitizers (e.g., metformin, pioglitazone, or rosiglitazone)
- Exogenous growth hormone therapy

Radiotherapy

See Disease Characteristics
No prior pelvic radiotherapy
No prior intensity-modulated radiotherapy
No concurrent radiotherapy for abdominal cancer
No concurrent hyperfractionated, split-course, or intensity-modulated radiotherapy
No brachytherapy prior to or after completion of all external beam radiotherapy

Surgery

No prior abdominal-perineal resection or other surgical procedure leaving the patient without a functioning rectum
No colostomy

Other

More than 30 days since other prior investigational drugs
No prior octreotide for cancer therapy-related diarrhea
No concurrent prophylactic antidiarrheal medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075868

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Locations

United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
California Cancer Center - Woodward Park Office
Fresno, California, United States, 93720
Leavey Cancer Center at Northridge Hospital Medical Center
Northridge, California, United States, 91328
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States, 95926
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States, 90301
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
Saint Agnes Medical Center
Fresno, California, United States, 93720-3397
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Torrance Memorial Medical Center
Torrance, California, United States, 90509
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Georgia
John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31904
United States, Illinois
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, United States, 46016
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, United States, 46202
United States, Iowa
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Nebraska
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Washoe Cancer Services at Washoe Medical Center - Reno
Reno, Nevada, United States, 89502
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, United States, 08103
Community Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
South Jersey Healthcare Regional Cancer Center
Vineland, New Jersey, United States, 08360
United States, New York
Long Island College Hospital
Brooklyn, New York, United States, 11201
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309-2090
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, United States, 44460
Cancer Treatment Center
Wooster, Ohio, United States, 44691
CCOP - Columbus
Columbus, Ohio, United States, 43215
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oklahoma
LaFortune Cancer Center at St. John Medical Center
Tulsa, Oklahoma, United States, 74104
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Institute of Oncology at Vilnius University
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Mercy Cancer Institute at Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Washington
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
United States, Wisconsin
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
Columbia St. Mary's Cancer Center
Milwaukee, Wisconsin, United States, 53211
West Allis Memorial Hospital
West Milwaukee, Wisconsin, United States, 53227
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Babu Zachariah, MD	H. Lee Moffitt Cancer Center and Research Institute
Investigator:	Jaffer A. Ajani, MD	M.D. Anderson Cancer Center

Study ID Numbers:	CDR0000349441, RTOG-0315
Study First Received:	January 9, 2004
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00075868 History of Changes
Health Authority:	United States: Federal Government