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Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer Clinical research trials and Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer. Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer  Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer
Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer
For Condition: Colon Cancer,Rectal Cancer,Diarrhea
Status: Not yet recruiting
Sponsor(s): University of Rochester , National Cancer Institute (NCI)
Synopsis: RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are receiving chemotherapy for colorectal cancer. It is not yet known whether octreotide is more effective than standard treatment for diarrhea. PURPOSE: Randomizedphase III trial to compare the effectiveness of octreotide with that of standard therapy in preventing diarrhea in patients who are receiving chemotherapy for colorectal cancer.
Details: OBJECTIVES: - Compare the proportion of patients with colorectal cancer with grade 3 or 4 diarrhea between days 28 and 84 when treated with octreotide versus standard care for chemotherapy-induced diarrhea. - Compare the change in chemotherapy dose in patients treated with these regimens. - Compare the proportion of patients with no diarrhea between days 28 and 168 when treated with these regimens. - Compare the proportion of patients requiring IV fluid resuscitation between days 28 and 168 when treated with these regimens. - Compare the proportion of patients requiring hospitalization due to dehydration secondary to diarrhea between days 28 and 168 when treated with these regimens. - Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to prior colostomy (yes vs no) and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Prior to chemotherapy, patients receive a single dose of octreotide subcutaneously. Patients who are tolerant receive octreotide intramuscularly beginning on day 1 of chemotherapy. Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity. - Arm II: Patients receive standard care. Quality of life is assessed at baseline and at days 28, 56, and 84. Patients are followed at day 28. PROJECTED ACCRUAL: A total of 626 patients (313 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of colon or rectal cancer - Planned chemotherapy with oxaliplatin, irinotecan, and/or fluorouracil that is expected to last at least 3 months - No regimens containing other chemotherapy agents - Chemotherapy may be for adjuvant, neoadjuvant, curative, or palliative intent - No growth hormone-secreting tumors - No diarrhea grade 2 or greater within the past 96 hours PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - No symptomatic liver disease - No clinical evidence of gallstones or gallbladder disease Renal - Not specified Other - No known sensitivity to octreotide or related drugs - No clinical evidence of current or impending bowel obstruction - No acromegaly or malignant carcinoid syndrome - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent interferon Chemotherapy - See Disease Characteristics - Prior chemotherapy allowed - Concurrent modulating agents (e.g., leucovorin calcium or levamisole) allowed Endocrine therapy - More than 7 days since prior insulin - No concurrent insulin - No concurrent exogenous growth hormone therapy Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - No concurrent cyclosporine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GaryMorrow, Study Chair, James P. Wilmot Cancer Center
Additional Information:
Study ID Numbers: CDR0000257579; URCC-CCC-01-16,NCI-P02-0233,URCC-U0116,URCC-CC-1202
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052975
Other Rectal Cancer Studies:
1. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
2. Combination Chemotherapy and Oblimersen in Treating Patients With Advanced Colorectal Cancer
3. Computerized Tomographic Colonography Compared With Standard Diagnostic Procedures in Detecting Colorectal Neoplasia
4. Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
5. Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
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Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer
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