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

NCT00033605 | Completed Phase 3 DMC

• 3 other identifiers: NCCTG-N00CACDR0000069304NCI-P02-0221
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer; Colorectal Cancer; Diarrhea; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Prostate Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific; Vaginal Cancer; Vulvar Cancer

Outcome Measures

Primary Outcomes (1)

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

  Up to 2 years

Secondary Outcomes (3)

• 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

  Up to 2 years

• Toxicity as assessed by NCI CTC version 2.0 weekly during pelvic radiotherapy

  Up to 2 years

• Importance that patients attach to various measures of bowel dysfunction as assessed by questionnaire at week 4 of radiotherapy and at 12 and 24 months after completion of radiotherapy

  Up to 2 years

Study Arms (2)

octreotide + radiation

EXPERIMENTAL

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.

Drug: octreotide acetate; Radiation: radiation

placebo + radiation

ACTIVE COMPARATOR

Patients receive placebo SC on day 1 and 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.

Other: placebo; Radiation: radiation

Interventions

octreotide acetate DRUG

octreotide + radiation

placebo OTHER

placebo + radiation

radiation RADIATION

octreotide + radiation; placebo + radiation

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Martenson JA, Halyard MY, Sloan JA, Proulx GM, Miller RC, Deming RL, Dick SJ, Johnson HA, Tai TH, Zhu AW, Keit J, Stien KJ, Atherton PJ. Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: results of North Central Cancer Treatment Group N00CA. J Clin Oncol. 2008 Nov 10;26(32):5248-53. doi: 10.1200/JCO.2008.17.1546. Epub 2008 Sep 2.

  PMID: 18768432 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Colorectal Neoplasms; Diarrhea; Endometrial Neoplasms; Fallopian Tube Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Sarcoma; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Octreotide; Radiation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fallopian Tube Diseases; Adnexal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Physical Phenomena

Study Officials

• James A. Martenson, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: July 13, 2016

Record last verified: 2016-07