Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea
Condition: Chemotherapy-induced Diarrhea
MeSH terms: Diarrhea
Intervention: Octreotide Long Acting Release; Standard Treatment
Intervention description: 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.; Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Colorectal cancer; diarrhea; drug therapy; octreotide; fluorouracil; irinotecan; capecitabine; prevention

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.
    

Eligibility criteria:

        Inclusion criteria:

          1. Providing a written informed consent

          2. Age between 18 and 80 years;

          3. Histological diagnosis of colorectal cancer, presence of metastatic disease and no
             prior systemic therapy for metastatic disease (prior adjuvant therapy will be allowed
             if completed 6 months or longer before inclusion in the study);

          4. 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;

          5. A performance status of 0 or 1 according to the Eastern Cooperative Oncology Group
             (ECOG) scale

          6. Adequate organ function and lab values within specific ranges

          7. Female patients of childbearing potential must have a negative serum pregnancy test
             within 7 days prior to registration;

          8. 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;

          9. No prior use of octreotide in any formulation.

        Exclusion criteria:

          1. Use of concomitant antineoplastic treatments, other than regimens containing either
             5-FU, capecitabine, or irinotecan with or without oxaliplatin, bevacizumab, or
             cetuximab;

          2. Previous or concomitant need for radiotherapy to the abdomen or pelvis;

          3. Indication of treatment, according to the judgment of the investigator, with
             erlotinib, gefitinib, panitumumab, or other EGFR-inhibitors other than cetuximab;

          4. 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);

          5. 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;

          6. 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;

          7. Active and ongoing systemic infection;

          8. Serious uncontrolled psychiatric illness;

          9. Ongoing pregnancy or lactation;

         10. Female patients who are pregnant or lactating, or are of childbearing potential and
             would not practice a medically acceptable method for birth control;

         11. 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;

         12. Use of any investigational agent within 30 days prior to enrollment in the study or
             foreseen use of an investigational agent during the study;

         13. History of chronic (≥ 30 nonconsecutive days) use of laxatives;

         14. Concurrent use of antidiarrheal agents;

         15. Inability to comply with the study protocol.

        Other protocol-defined inclusion/exclusion criteria may apply.