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A Prospective, Randomized Trial of Sandostatin LAR Depot for the Prevention of Irinotecan-Induced Diarrhea in Patients With Metastatic Colorectal Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Diarrhea

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Trial Information

A Prospective, Randomized Trial of Sandostatin LAR Depot for the Prevention of Irinotecan-Induced Diarrhea in Patients With Metastatic Colorectal Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Kurt Sizer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068215

NCT ID:

NCT00006269

Start Date:

December 1999

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Diarrhea
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • diarrhea
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Diarrhea

Name

Location
Novartis Pharmaceuticals Corporation East Hanover, New Jersey  07936
Theradex Princeton, New Jersey  08543