Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer

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Brief Title

Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer

Official Title

A Randomized, Double Blind, Placebo-Controlled Phase III Study To Determine The Efficacy Of Sandostatin LAR® Depot (Octreotide Acetate) In Preventing Or Reducing The Severity Of Chemoradiation-Induced Diarrhea In Patients With Anal Or Rectal Cancer

Brief Summary

      RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who
      are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether
      octreotide is effective in treating diarrhea.

      PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing
      diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  Determine the ability of octreotide to prevent the incidence of moderate, severe, or
           life-threatening chemoradiotherapy-induced diarrhea (grades 2-4) in patients with anal
           or rectal cancer.

      Secondary

        -  Compare the quality of life of patients treated with this drug vs placebo.

        -  Compare the number of hospitalizations and use of antidiarrheal agents (e.g., Imodium®)
           related to diarrhea (or its complications) in patients treated with these drugs.

        -  Compare treatment delays and/or dose reductions (chemotherapy and radiotherapy) in
           patients treated with these drugs.

      OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients
      are stratified according to radiotherapy dose (< 50 Gy vs ≥ 50 Gy), chemotherapy dose (bolus
      vs continuous), and gender. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive octreotide* intramuscularly (IM) 4-7 days before the start of
           chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.

        -  Arm II: Patients receive placebo* IM 4-7 days before the start of chemoradiotherapy and
           on day 22 (± 3 days) during chemoradiotherapy.

      NOTE: *Patients receive a total of 2 injections of octreotide or placebo

      In both arms, treatment continues in the absence of unacceptable toxicity.

      Quality of life is assessed at baseline, at the completion of chemoradiotherapy, and at 3, 6,
      9, and 15 months from the start of chemoradiotherapy.

      Patients are followed at 3, 6, 9, and 15 months from the start of chemoradiotherapy.

      PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this
      study within 2 years.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Prevention of the incidence of moderate, severe, or life-threatening diarrhea

Secondary Outcome

 Quality of life

Condition

Anal Cancer

Intervention

octreotide acetate

Study Arms / Comparison Groups

 Sandostatin LAR® Depot
Description:  Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

233

Start Date

December 2003


Primary Completion Date

August 2006

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary anal or rectal cancer

               -  No metastasis beyond the pelvic regional nodes

          -  Must be scheduled to receive chemoradiotherapy

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Liver function tests < 3 times upper limit of normal

          -  No prior hepatic disease

        Renal

          -  Not specified

        Gastrointestinal

          -  No prior chronic or acute regional enteritis

          -  No malabsorption syndrome

          -  No prior inflammatory bowel disease that may exacerbate the radiotherapy toxicity

          -  No grade 2 or greater uncontrollable diarrhea at baseline

          -  No prior cholecystitis or gallstones, unless a cholecystectomy has been performed

          -  No prior incontinence of stool

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No uncontrolled diabetes (e.g., fasting glucose > 250 mg/dL)

          -  No prior allergy or hypersensitivity to study drug or other related drug or compound

          -  No other medical condition or mental impairment that would preclude study treatment
             and compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

          -  Prior chemotherapy allowed

        Endocrine therapy

          -  At least 6 months since prior administration of any of the following:

               -  Glucocorticoid therapy

               -  Insulin sensitizers (e.g., metformin, pioglitazone, or rosiglitazone)

               -  Exogenous growth hormone therapy

        Radiotherapy

          -  See Disease Characteristics

          -  No prior pelvic radiotherapy

          -  No prior intensity-modulated radiotherapy

          -  No concurrent radiotherapy for abdominal cancer

          -  No concurrent hyperfractionated, split-course, or intensity-modulated radiotherapy

          -  No brachytherapy prior to or after completion of all external beam radiotherapy

        Surgery

          -  No prior abdominal-perineal resection or other surgical procedure leaving the patient
             without a functioning rectum

          -  No colostomy

        Other

          -  More than 30 days since other prior investigational drugs

          -  No prior octreotide for cancer therapy-related diarrhea

          -  No concurrent prophylactic antidiarrheal medication
      

Gender

All

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Babu Zachariah, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00075868

Organization ID

RTOG-0315

Secondary IDs

CDR0000349441

Responsible Party

Sponsor

Study Sponsor

Radiation Therapy Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Babu Zachariah, MD, Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute


Verification Date

November 2015