Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	E-E1295 CLB-9770, SWOG-E1295, NCI-P97-0081, NCT00003057

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.

Entry Criteria

Disease Characteristics:

Histologically confirmed colorectal carcinoma

At least grade 2 diarrhea as a consequence of chemotherapy

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

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

Expected Enrollment

This study will accrue a total of 500 patients.

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Scott Wadler, MD, Protocol chair(Contact information may not be current)		Ph: 718-904-2754

Southwest Oncology Group

Mace Rothenberg, MD, FACP, Protocol chair		Ph: 615-936-1796; 800-811-8480 Email: mace.rothenberg@vanderbilt.edu

Cancer and Leukemia Group B

Bhoomi Mehrotra, MD, Protocol chair		Ph: 718-470-8934; 800-371-7111

Registry Information
Official Title		Randomized Trial of High-Dose Versus Conventional Dose Octreotide Acetate Versus Loperamide in the Treatment of Chemotherpay-Related Diarrhea in Patients with Colorectal Cancer
Trial Start Date		1996-11-19
Trial Completion Date		2000-05-19
Registered in ClinicalTrials.gov		NCT00003057
Date Submitted to PDQ		1997-08-18
Information Last Verified		2009-01-27