Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea
- Conditions
- Chemotherapy-induced Diarrhea
- Interventions
- Other: Standard Treatment
- Registration Number
- NCT00582426
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Eligible patients will have a diagnosis of colorectal cancer, and will be candidates to adjuvant chemotherapy or first-line chemotherapy for metastatic disease with a regimen containing fluorouracil, capecitabine and/or irinotecan. Eligible chemotherapy regimens include Irinotecan, Leucovorin (folinic acid), and Fluorouracil(IFL), Leucovorin, Fluorouracil, and Irinotecan (FOLFIRI), combinations of Irinotecan and Capecitabine, the Roswell Park regimen and the Mayo Clinic regimen, all of them without or with Oxaliplatin, Bevacizumab or Cetuximab. Patients receiving Erlotinib, or other Tyrosine-kinase, Epidermal Growth Factor Receptor (EGFR)-inhibitors, will not be eligible.
The acute treatment for diarrhea will be left to physician's discretion in both groups. Patients in the control arm will be treated without Octreotide LAR. Patients in the experimental arm 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 chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first. Patient evaluation will be done at each cycle for efficacy and toxicity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Octreotide Long Acting Release Octreotide Long Acting Release Prevention of Chemotherapy Induced Diarrhea (CID) Standard Treatment Standard Treatment Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
- Primary Outcome Measures
Name Time Method Percentage of Participants Developing Diarrhea (Grade 1 to 4) 6 month overall 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) Day 56, Day 84, Day 112, Day 140, Day 168 Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as \> 20 mm with conventional techniques (CT, MRI) or as \> 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.
Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D) Baseline to Day 168 Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point.
Number of Episodes of Diarrhea by Patient 6 months overall Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis.
Number of Episodes of Diarrhea by Patient by Cycle at each cycle (28 days per cycle) Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.)
Percentage of Patients by Grade of Diarrhea 6 months overall Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse 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.
Percentage of Episodes by Grade 6 months overall Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 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.
Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea 6 months overall For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered.
Percentage of Participants Who Need Opioids for Control of Diarrhea 6 months overall Percentage of Patients Hospitalized Due to Diarrhea 6 months overall Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea 6 months overall
Trial Locations
- Locations (11)
Biocâncer
🇧🇷Belo Horizonte, Brazil
Hospital Sao Lucas- Faculdade de Medicina da PUCRS
🇧🇷Porto Alegre, Brazil
Clínica AMO
🇧🇷Salvador, Brazil
Instituto Arnaldo Vieira de Carvalho - IAVC
🇧🇷São Paulo, Brazil
CEPON-Centro de Pesquisas Oncologicas
🇧🇷Florianópolis, Brazil
Hosital Alemão Oswaldo Cruz
🇧🇷São Paulo, Brazil
Hospital A C Camargo/ Fundação Antonio Prudente
🇧🇷São Paulo, Brazil
Hospital das Clínicas - FMUSP
🇧🇷São Paulo, Brazil
Nucleo de Oncologia da Bahia
🇧🇷Salvador, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo André, Brazil
UNIFESP
🇧🇷São Paulo, Brazil