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Octreotide in the Prevention of Diarrhea in Patients Receiving Irinotecan for Metastatic Colon Cancer

Primary Purpose

Colorectal Cancer, Diarrhea

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
octreotide acetate
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically, cytologically, and/or radiographically proven metastatic colorectal cancer with disease recurrence or progression following fluorouracil (5-FU) based chemotherapy Acceptable 5-FU based regimens include capecitabine, 5-FU-uracil, floxuridine, S-1, or eniluracil combined with 5-FU Acceptable 5-FU modulating agents include levamisole and leucovorin calcium Measurable or evaluable disease No known brain or leptomeningeal disease except previously irradiated lesions that do not require corticosteroids and are asymptomatic PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension No unstable angina No congestive heart failure No myocardial infarction within the past 6 months No serious cardiac arrhythmia Pulmonary: No interstitial pneumonia or fibrosis Gastrointestinal: No symptomatic cholelithiasis No gastrointestinal disease that may result in nontherapy related diarrhea Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other medical or surgical disease that may result in nontherapy related diarrhea No other severe disease that would preclude study No mental incapacity or psychiatric illness that would preclude study No uncontrolled diabetes mellitus No hypersensitivity to octreotide or any of its excipients No active or uncontrolled infection HIV negative No active second malignancy within the past 5 years except nonmelanomatous skin cancer or cervical carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior irinotecan At least 7 days since other prior chemotherapy and recovered Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: No ostomy Other: Greater than 1 month since prior investigational agent No concurrent investigational agent No concurrent phenytoin, phenobarbital, valproic acid, or other antiepileptic therapy

Sites / Locations

  • Novartis Pharmaceuticals Corporation
  • Theradex

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
May 24, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00006269
Brief Title
Octreotide in the Prevention of Diarrhea in Patients Receiving Irinotecan for Metastatic Colon Cancer
Official Title
A Prospective, Randomized Trial of Sandostatin LAR Depot for the Prevention of Irinotecan-Induced Diarrhea in Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Study Start Date
December 1999 (undefined)
Primary Completion Date
December 1999 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Octreotide may be effective in preventing diarrhea that is caused by treatment with irinotecan. PURPOSE: Randomized phase III trial to study the effectiveness of octreotide in preventing diarrhea in patients who are receiving irinotecan for metastatic colon cancer.
Detailed Description
OBJECTIVES: I. Compare the incidence of grade 2-4 diarrhea after completion of irinotecan in patients with metastatic colorectal cancer treated with octreotide vs placebo. II. Compare the duration of diarrhea and need for irinotecan dose reduction/ delay and hospitalization in patients treated with these 2 regimens. III. Collect data on tumor response and 1 year survival in patients treated with these 2 regimens. IV. Determine the pharmacokinetics and interaction of irinotecan and octreotide in a subset of these patients. OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to prior pelvic irradiation (yes vs no), age (under 70 vs 70 and over), and ECOG performance status (0 vs 1 or 2). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive octreotide intramuscularly (IM) once. Beginning 10-14 days later, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive octreotide IM on the same day as irinotecan. Arm II: Patients receive placebo IM once. Beginning 10-14 days later, patients receive irinotecan as in arm I. Patients also receive placebo IM on the same day as irinotecan. Therapy continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months through year 1. PROJECTED ACCRUAL: A total of 300 patients (150 per arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Diarrhea
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, diarrhea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
octreotide acetate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically, cytologically, and/or radiographically proven metastatic colorectal cancer with disease recurrence or progression following fluorouracil (5-FU) based chemotherapy Acceptable 5-FU based regimens include capecitabine, 5-FU-uracil, floxuridine, S-1, or eniluracil combined with 5-FU Acceptable 5-FU modulating agents include levamisole and leucovorin calcium Measurable or evaluable disease No known brain or leptomeningeal disease except previously irradiated lesions that do not require corticosteroids and are asymptomatic PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension No unstable angina No congestive heart failure No myocardial infarction within the past 6 months No serious cardiac arrhythmia Pulmonary: No interstitial pneumonia or fibrosis Gastrointestinal: No symptomatic cholelithiasis No gastrointestinal disease that may result in nontherapy related diarrhea Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other medical or surgical disease that may result in nontherapy related diarrhea No other severe disease that would preclude study No mental incapacity or psychiatric illness that would preclude study No uncontrolled diabetes mellitus No hypersensitivity to octreotide or any of its excipients No active or uncontrolled infection HIV negative No active second malignancy within the past 5 years except nonmelanomatous skin cancer or cervical carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior irinotecan At least 7 days since other prior chemotherapy and recovered Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: No ostomy Other: Greater than 1 month since prior investigational agent No concurrent investigational agent No concurrent phenytoin, phenobarbital, valproic acid, or other antiepileptic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Sizer, MD
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Pharmaceuticals Corporation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Facility Name
Theradex
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08543
Country
United States

12. IPD Sharing Statement

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Octreotide in the Prevention of Diarrhea in Patients Receiving Irinotecan for Metastatic Colon Cancer

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