Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00033605

Purpose

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.

Condition	Intervention	Phase
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	Drug: octreotide acetate	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Diarrhea Ovarian Cancer Prostate Cancer Soft Tissue Sarcoma Vaginal Cancer Vulvar Cancer

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Study Start Date:	April 2002
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

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.

PROJECTED ACCRUAL: A minimum of 125 patients (62 per treatment arm) will be accrued for this study within 38 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

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:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

No other concurrent octreotide

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033605

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

James A. Martenson, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 Sep 2; [Epub ahead of print]

Martenson JA, Sloan JA, Deming RL, et al.: Phase III double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea during pelvic radiation therapy: results of North Central Cancer Treatment Group protocol N00CA. [Abstract] J Clin Oncol 24 (Suppl 18): A-8506, 469s, 2006.

Study ID Numbers:	CDR0000069304, NCCTG-N00CA, NCI-P02-0221
Study First Received:	April 9, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00033605 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

diarrhea
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
stage III cervical cancer
stage IB cervical cancer
stage IIB cervical cancer
stage IVB cervical cancer
stage IIA cervical cancer
stage IVA cervical cancer
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III vulvar cancer
stage IV vulvar cancer

stage 0 vaginal cancer
stage I vaginal cancer
stage II vaginal cancer
stage III vaginal cancer
stage IVA vaginal cancer
stage IVB vaginal cancer
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Prostatic Diseases
Genital Neoplasms, Male
Signs and Symptoms, Digestive
Antineoplastic Agents
Gonadal Disorders
Gastrointestinal Diseases
Colonic Diseases
Octreotide
Vaginal Diseases
Urogenital Neoplasms
Ovarian Diseases
Rectal Diseases
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Signs and Symptoms

Endometrial Neoplasms
Neoplasms by Site
Vulvar Neoplasms
Therapeutic Uses
Uterine Neoplasms
Endocrine Gland Neoplasms
Vaginal Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Ovarian Neoplasms
Diarrhea
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Genital Neoplasms, Female
Uterine Diseases

ClinicalTrials.gov processed this record on November 09, 2009