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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Anal Cancer, Colorectal Cancer, Drug/Agent Toxicity by Tissue/Organ, Radiation Enteritis
Both
Anal Cancer, Colorectal Cancer, Drug/Agent Toxicity by Tissue/Organ, Radiation Enteritis
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Prevention of the incidence of moderate, severe, or life-threatening diarrhea
Principal Investigator
Babu Zachariah, MD
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000349441
NCT ID:
NCT00075868
Start Date:
December 2003
Completion Date:
Related Keywords:
- Anal Cancer
- Colorectal Cancer
- Drug/Agent Toxicity by Tissue/Organ
- Radiation Enteritis
- radiation enteritis
- drug/agent toxicity by tissue/organ
- stage I rectal cancer
- stage II rectal cancer
- stage III rectal cancer
- stage IIIA anal cancer
- stage IIIB anal cancer
- recurrent anal cancer
- stage I anal cancer
- stage II anal cancer
- recurrent rectal cancer
- Anus Neoplasms
- Rectal Neoplasms
- Colorectal Neoplasms
- Enteritis
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| St. Rita's Medical Center | Lima, Ohio 45801 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
| Ball Memorial Hospital | Muncie, Indiana 47303-3499 |
| Cape Cod Hospital | Hyannis, Massachusetts 02601 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| New York Methodist Hospital | Brooklyn, New York 11215-3609 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
| Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| SUNY Downstate Medical Center | Brooklyn, New York 11203 |
| Central Baptist Hospital | Lexington, Kentucky 40503 |
| Trinity Cancer Care Center | Minot, North Dakota 58701 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
| Torrance Memorial Medical Center | Torrance, California 90505 |
| Sibley Memorial Hospital | Washington, District of Columbia 20016 |
| Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
| McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
| St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
| Fox Chase Cancer Center at St. Francis Medical Center | Trenton, New Jersey 08629 |
| Iredell Memorial Hospital | Statesville, North Carolina 28677 |
| LaFortune Cancer Center at St. John Medical Center | Tulsa, Oklahoma 74104 |
| Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
| Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
| Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Providence St. Vincent Medical Center | Portland, Oregon 97225 |
| Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
| Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
| Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
| California Cancer Center - Woodward Park Office | Fresno, California 93720 |
| Leavey Cancer Center at Northridge Hospital Medical Center | Northridge, California 91325 |
| Pomona Valley Hospital Medical Center | Pomona, California 91767 |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque, Iowa 52001 |
| Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
| Washoe Cancer Services at Washoe Medical Center - Reno | Reno, Nevada 89502 |
| South Jersey Healthcare Regional Cancer Center | Millville, New Jersey 08332 |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| Institute of Oncology at Vilnius University | Portland, Oregon 97227 |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
| All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin 53405 |
| West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
| Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
| Saint Agnes Medical Center | Fresno, California 93720-3397 |
| Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | Inglewood, California 90301 |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
| St. John's Cancer Center at St. John's Medical Center | Anderson, Indiana 46016 |
| Long Island College Hospital | Brooklyn, New York 11201 |
| Mercy Cancer Institute at Mercy Hospital | Pittsburgh, Pennsylvania 15219 |
| Lipson Cancer and Blood Center at Rochester General Hospital | Rochester, New York 14621 |
| Community Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
| Veterans Affairs Medical Center - Indianapolis | Indianapolis, Indiana 46202 |
| John B. Amos Community Cancer Center | Columbus, Georgia 31902 |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
| Columbia St. Mary's Cancer Center | Milwaukee, Wisconsin 53211 |
