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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033605
• Other study ID #: NCCTG-N00CA
• Secondary ID: CDR0000069304NCI
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2002
• Last updated: July 12, 2016
• Start date: April 2002
• Est. completion date: July 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Drug:
• octreotide acetate

Other:
• placebo

Radiation:
• radiation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

References & 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 recei — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy		Up to 2 years	No
Secondary	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	No
Secondary	Toxicity as assessed by NCI CTC version 2.0 weekly during pelvic radiotherapy		Up to 2 years	Yes
Secondary	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	No