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
octreotide acetate
+ Placebo
Anus Diseases+16
+ Anus Neoplasms
+ Diarrhea
Supportive Care Study
Summary
Study start date: December 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.233 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 112 locations
Foundation for Cancer Research and Education
Phoenix, United StatesEnloe Cancer Center at Enloe Medical Center
Chico, United StatesSaint Agnes Medical Center
Fresno, United States