Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

Brief Title

Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

Official Title

Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy

Brief Summary

      RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who
      are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is
      effective for diarrhea.

      PURPOSE: Randomized phase III trial to determine the effectiveness of octreotide in
      preventing diarrhea in patients who are undergoing radiation therapy to the pelvis.
    

Detailed Description

      OBJECTIVES:

        -  Determine the effectiveness of octreotide in reducing acute treatment-related diarrhea
           in patients receiving external-beam radiotherapy to the pelvis.

        -  Determine the effectiveness of this drug in reducing chronic treatment-related bowel
           dysfunction in these patients.

        -  Determine the toxicity of this drug in these patients.

        -  Assess the importance that these patients attach to various measures of bowel function.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to prior anterior resection of the rectum (yes vs no), total planned
      cumulative dose of radiotherapy, including boost fields (4,500-5,350 cGy vs 5,351-6,000 cGy
      vs more than 6,000 cGy), use of concurrent fluorouracil (none vs bolus vs continuous
      infusion), use of concurrent leucovorin calcium (yes vs no), use of concurrent cisplatin (yes
      vs no), superior border of initial field (at or inferior to the L4-5 interspace vs superior
      to the L4-5 interspace), planned intracavitary brachytherapy (yes vs no), and primary site of
      disease (rectal cancer vs prostate cancer vs gynecological cancer vs other). Beginning no
      later than the fourth day of radiotherapy, patients are randomized to one of two treatment
      arms.

        -  Arm I: Patients receive short-acting octreotide subcutaneously (SC) on day 1 and
           long-acting octreotide intramuscularly (IM) on days 2 and 29.

        -  Arm II: Patients receive placebo SC on day 1 and IM on days 2 and 29. In both arms,
           treatment continues in the absence of unacceptable toxicity or the development of severe
           diarrhea.

      Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and
      then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy.

      Patients are followed weekly for 4 weeks and then at 1 and 2 years.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy

Secondary Outcome

 Reduction of patient-reported bowel dysfunction as assessed by the bowel function questionnaire weekly during radiotherapy, weekly for 4 weeks after radiotherapy, and 12 and 24 months after completion of radiotherapy

Condition

Cervical Cancer

Intervention

octreotide acetate

Study Arms / Comparison Groups

 octreotide + radiation

Description:  Patients receive short-acting octreotide subcutaneously (SC) on day 1 and long-acting octreotide intramuscularly (IM) on days 2 and 29.
Treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea.
Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy.
Patients are followed weekly for 4 weeks and then at 1 and 2 years.

Publications

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

Recruitment Status

Drug

Estimated Enrollment

130

Start Date

April 2002

Completion Date

July 2006

Primary Completion Date

July 2006

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed cancer in the pelvis

          -  Plan to receive continuous definitive or adjuvant external-beam radiotherapy to the
             pelvis or pelvis and para-aortic lymph nodes (total planned dose of 4,500-5,350 cGy)

               -  Entire pelvis must be encompassed by planned radiotherapy field (superior border
                  not inferior to the most inferior aspect of sacroiliac joints)

               -  Portions of rectum may have special blocking depending on disease site

               -  Planned treatment for once-daily radiotherapy 4-5 times a week (planned daily
                  dose 170-210 cGy)

               -  No planned split-course radiotherapy

               -  No planned interstitial brachytherapy prior to completion of external-beam
                  radiotherapy

               -  Planned intracavitary radiotherapy allowed

               -  No planned cytotoxic chemotherapy agents concurrently with radiotherapy except
                  fluorouracil with or without leucovorin calcium or cisplatin

               -  Entered on study before the third radiotherapy fraction

          -  No current or prior metastases beyond pelvic or para-aortic lymph nodes

          -  No grade 3 or greater diarrhea, rectal bleeding, or abdominal cramping prior to
             radiotherapy

          -  No incontinence of stool

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-2

        Renal:

          -  No chronic renal failure

          -  Creatinine less than 2 times upper limit of normal (for patients with history of renal
             disease)

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known allergy to octreotide

          -  No history of inflammatory bowel disease

          -  No other concurrent medical condition that would preclude study participation

          -  No history of cholecystitis unless prior cholecystectomy

        PRIOR CONCURRENT THERAPY:

        Radiotherapy:

          -  See Disease Characteristics

          -  No prior radiotherapy to the pelvis

        Surgery:

          -  See Disease Characteristics

          -  No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure
             resulting in non-functioning rectum
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

James A. Martenson, MD, , 

NCT ID

NCT00033605

Organization ID

NCCTG-N00CA

Secondary IDs

CDR0000069304

Responsible Party

Sponsor

Study Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

James A. Martenson, MD, Study Chair, Mayo Clinic

Verification Date

July 2016