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Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer conditions. Clinical Trials Search.org is a website committed 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 health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like 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 for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally 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. Subjects frequently get the best healthcare possible for their Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting 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 Diarrhea Studies:
1. Genetic Study of Young Patients With Colorectal Cancer
2. Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
3. Interleukin-12 in Treating Patients With Cancer in the Abdomen
4. Phase I Study of SU006668 in Patients With Advanced Solid Tumors
5. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
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Octreotide in Preventing Diarrhea in Patients Receiving Chemotherapy for Colorectal Cancer
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