Status:
COMPLETED
Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anal Cancer
Colorectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief Summary
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 effec...
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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00075868
Start Date
December 1 2003
Last Update
November 17 2015
Active Locations (112)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
2
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
3
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States, 95926
4
Saint Agnes Medical Center
Fresno, California, United States, 93720-3397