Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
Anal Cancer, Colorectal Cancer, Drug/Agent Toxicity by Tissue/Organ
About this trial
This is an interventional supportive care trial for Anal Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- Mobile Infirmary Medical Center
- Foundation for Cancer Research and Education
- Enloe Cancer Center at Enloe Medical Center
- Saint Agnes Medical Center
- California Cancer Center - Woodward Park Office
- Sutter Health Western Division Cancer Research Group
- Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
- Leavey Cancer Center at Northridge Hospital Medical Center
- CCOP - Bay Area Tumor Institute
- Pomona Valley Hospital Medical Center
- Radiological Associates of Sacramento Medical Group, Incorporated
- University of California Davis Cancer Center
- Torrance Memorial Medical Center
- Memorial Hospital Cancer Center
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- Sibley Memorial Hospital
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- University of Florida Shands Cancer Center
- Memorial Cancer Institute at Memorial Regional Hospital
- Baptist Cancer Institute - Jacksonville
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- University of Miami Sylvester Comprehensive Cancer Center
- Baptist-South Miami Regional Cancer Program
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Veterans Affairs Medical Center - Tampa (Haley)
- John B. Amos Community Cancer Center
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
- St. John's Cancer Center at St. John's Medical Center
- Indiana University Cancer Center
- Veterans Affairs Medical Center - Indianapolis
- Ball Memorial Hospital
- Wendt Regional Cancer Center at Finley Hospital
- Central Baptist Hospital
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- Cape Cod Hospital
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
- CCOP - Michigan Cancer Research Consortium
- Josephine Ford Cancer Center at Henry Ford Hospital
- CCOP - Grand Rapids
- West Michigan Cancer Center
- Sparrow Regional Cancer Center
- William Beaumont Hospital - Royal Oak Campus
- Mayo Clinic Cancer Center
- Regional Cancer Center at Singing River Hospital
- CCOP - Kansas City
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Siteman Cancer Center at Barnes-Jewish Hospital
- Methodist Cancer Center at Methodist Hospital - Omaha
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Washoe Cancer Services at Washoe Medical Center - Reno
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
- Monmouth Medical Center
- Community Regional Cancer Center at Community Medical Center
- Fox Chase Cancer Center at St. Francis Medical Center
- South Jersey Healthcare Regional Cancer Center
- Long Island College Hospital
- SUNY Downstate Medical Center
- New York Methodist Hospital
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- Lipson Cancer and Blood Center at Rochester General Hospital
- Duke Comprehensive Cancer Center
- Iredell Memorial Hospital
- Trinity Cancer Care Center
- Akron City Hospital
- Aultman Hospital Cancer Center at Aultman Health Foundation
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- St. Rita's Medical Center
- Hillcrest Cancer Center at Hillcrest Hospital
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- Cancer Treatment Center
- LaFortune Cancer Center at St. John Medical Center
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Institute of Oncology at Vilnius University
- Legacy Meridian Park Hospital
- Bryn Mawr Hospital
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Paoli Memorial Hospital
- Allegheny Cancer Center at Allegheny General Hospital
- Mercy Cancer Institute at Mercy Hospital
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- Reading Hospital and Medical Center
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- CCOP - Greenville
- CCOP - Upstate Carolina
- CCOP - Scott and White Hospital
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- St. Joseph Hospital Community Cancer Center
- Southwest Washington Medical Center Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- St. Vincent Hospital Regional Cancer Center
- Columbia St. Mary's Cancer Center
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
- All Saints Cancer Center at All Saints Healthcare
- West Allis Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Sandostatin LAR® Depot
Placebo
Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)