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Randomized Trial of High-Dose Versus Conventional Dose Octreotide Acetate Versus Loperamide in the Treatment of Chemotherpay-Related Diarrhea in Patients With Colorectal Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Diarrhea

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Trial Information

Randomized Trial of High-Dose Versus Conventional Dose Octreotide Acetate Versus Loperamide in the Treatment of Chemotherpay-Related Diarrhea in Patients With Colorectal Cancer


OBJECTIVES: I. Determine the safety and efficacy of octreotide acetate versus conventional
therapy with loperamide hydrochloride for chemotherapy related diarrhea in patients with
advanced colorectal malignancies undergoing chemotherapy with fluorouracil or fluorouracil
based regimens.

OUTLINE: This is a prospective, randomized, parallel, open label, multicenter study.
Patients are stratified by therapy, grade of diarrhea, and prior use of loperamide
hydrochloride or octreotide acetate. Patients undergo 1 of 3 treatments. Patients receive
either low doses of octreotide (arm A) or high doses of octreotide (arm B) subcutaneously 3
times daily for 5 days. Patients in arm C receive oral doses of loperamide following each
unformed stool for 5 days. A diary is completed by patients to record medications and bowel
history. Treatment continues if diarrhea persists beyond day 5, but will be considered a
treatment failure. If diarrhea continues to worsen, patients are removed from study. All
patients are followed for 24 days.

PROJECTED ACCRUAL: This study will accrue a total of 500 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed colorectal carcinoma At least grade 2
diarrhea as a consequence of chemotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Concurrent enrollment into SWOG-9420 protocol allowed No sensitivity to octreotide
acetate or loperamide hydrochloride Eligible if less than 24 hours since prior loperamide
or octreotide and no resolution of diarrhea Not pregnant or lactating Effective
contraception required of fertile patients Not HIV positive No idiopathic ulcerative
colitis or Crohn's disease, acute stool culture positive bacterial colitis,
pseudomembranous colitis, short bowel syndrome, enteroenteric fistulae, chronic
pancreatitis, ischemic bowel disease, or gastrointestinal disorders known to cause
diarrhea Absence of definitive culture results required

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy
with a fluoropyrimidine alone or in combination with an accepted modulating agent
(leucovorin, levamisole, methotrexate, interferon, PALA, or hydroxyurea) required Prior
chemotherapy with uracil mustard and tegafur (UFT) allowed No concurrent chemotherapy
allowed during study Endocrine therapy: Not specified Radiotherapy: No whole pelvic or
abdominal radiation therapy allowed Surgery: No colectomy, coloanal anastamosis,
abdominoperineal resection, or colostomy allowed Other: No antidiarrheal agents (e.g.,
diphenoxylate hydrochloride, elixir paregoric, opium tincture or tincture of belladonna,
or kaolin) during study No cyclosporine allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Scott Wadler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

United States: Federal Government

Study ID:

CDR0000065713

NCT ID:

NCT00003057

Start Date:

November 1996

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Diarrhea
  • colon cancer
  • rectal cancer
  • diarrhea
  • Colorectal Neoplasms
  • Diarrhea

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330