Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea

NCT00582426 | Completed Phase 3 Results

• 1 other identifier: CSMS995AIC04
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 11

Brief Summary

This study will evaluate the efficacy of Octreotide LAR in preventing chemotherapy-induced diarrhea (with regimens that contain 5 fluorouracil, irinotecan and capecitabine)in patients with colorectal cancer.

Conditions

Chemotherapy-induced Diarrhea

Keywords

Colorectal cancer; diarrhea; drug therapy; octreotide; fluorouracil; irinotecan; capecitabine; prevention

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Developing Diarrhea (Grade 1 to 4)

  The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.

  6 month overall

Secondary Outcomes (10)

• Number of Episodes of Diarrhea by Patient

  6 months overall

• Number of Episodes of Diarrhea by Patient by Cycle

  at each cycle (28 days per cycle)

• Percentage of Patients by Grade of Diarrhea

  6 months overall

• Percentage of Episodes by Grade

  6 months overall

• Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea

  6 months overall

Study Arms (2)

Octreotide Long Acting Release

EXPERIMENTAL

Prevention of Chemotherapy Induced Diarrhea (CID)

Drug: Octreotide Long Acting Release

Standard Treatment

OTHER

Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.

Other: Standard Treatment

Interventions

Octreotide Long Acting Release DRUG

Patients will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until first-line chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first.

Also known as: Octreotide LAR, Sandostatin LAR

Octreotide Long Acting Release

Standard Treatment OTHER

Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.

Standard Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Providing a written informed consent
• Age between 18 and 80 years;
• Indication of treatment, according to the judgment of the investigator, with a chemotherapy regimen containing either 5-FU, capecitabine, or irinotecan; any such regimen may also include oxaliplatin, bevacizumab, or cetuximab;
• A performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale
• Adequate organ function and lab values within specific ranges
• Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration;
• Fertile patients (male or female) must agree to use an acceptable method of contraception to avoid pregnancy for the duration of the study and for 3 months after study termination;
• No prior use of octreotide in any formulation.

You may not qualify if:

• Use of concomitant antineoplastic treatments, other than regimens containing either 5-FU, capecitabine, or irinotecan with or without oxaliplatin, bevacizumab, or cetuximab;
• Previous or concomitant need for radiotherapy to the abdomen or pelvis;
• Indication of treatment, according to the judgment of the investigator, with erlotinib, gefitinib, panitumumab, or other EGFR-inhibitors other than cetuximab;
• A second malignancy (except in situ carcinoma of the cervix, in situ carcinoma of the bladder, adequately treated basal-cell or squamous-cell carcinoma of the skin, or another malignancy treated more than 5 years prior to enrollment and without recurrence);
• Any type of condition leading to chronic diarrhea, including, but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), chronic diarrhea of presumed or confirmed infectious origin, and irritable bowel syndrome;
• Active or uncontrolled concurrent medical condition, including, but not limited to, unstable angina, congestive heart failure, coronary artery disease, hypertension, diabetes mellitus, and hyper- or hypothyroidism;
• Active and ongoing systemic infection;
• Serious uncontrolled psychiatric illness;
• Ongoing pregnancy or lactation;
• Female patients who are pregnant or lactating, or are of childbearing potential and would not practice a medically acceptable method for birth control;
• Lesions that have been irradiated cannot be included as sites of measurable disease. If the only measurable lesion was previously irradiated the patient cannot be included;
• Use of any investigational agent within 30 days prior to enrollment in the study or foreseen use of an investigational agent during the study;
• History of chronic (≥ 30 nonconsecutive days) use of laxatives;
• Concurrent use of antidiarrheal agents;
• Inability to comply with the study protocol.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Biocâncer

Belo Horizonte, Brazil

Location

CEPON-Centro de Pesquisas Oncologicas

Florianópolis, Brazil

Location

Hospital Sao Lucas- Faculdade de Medicina da PUCRS

Porto Alegre, Brazil

Location

Clínica AMO

Salvador, Brazil

Location

Nucleo de Oncologia da Bahia

Salvador, Brazil

Location

Faculdade de Medicina do ABC

Santo André, Brazil

Location

Hosital Alemão Oswaldo Cruz

São Paulo, Brazil

Location

Hospital A C Camargo/ Fundação Antonio Prudente

São Paulo, Brazil

Location

Hospital das Clínicas - FMUSP

São Paulo, Brazil

Location

Instituto Arnaldo Vieira de Carvalho - IAVC

São Paulo, Brazil

Location

UNIFESP

São Paulo, Brazil

Location

Related Publications (1)

• Hoff PM, Saragiotto DF, Barrios CH, del Giglio A, Coutinho AK, Andrade AC, Dutra C, Forones NM, Correa M, Portella Mdo S, Passos VQ, Chinen RN, van Eyll B. Randomized phase III trial exploring the use of long-acting release octreotide in the prevention of chemotherapy-induced diarrhea in patients with colorectal cancer: the LARCID trial. J Clin Oncol. 2014 Apr 1;32(10):1006-11. doi: 10.1200/JCO.2013.50.8077. Epub 2014 Feb 10.

  PMID: 24516038 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Diarrhea

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations were the small number of patients who received irinotecan and small proportion of patients with grade III and IV diarrhea. It is not possible to generalize our results for these populations. Study wasn't blinded or placebo-controlled.

Results Point of Contact

• Title: Study Director
• Organization: Novartis

1-800-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: April 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 4, 2015
• Results First Posted: March 27, 2012

Record last verified: 2015-04

Locations

BR (11)