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

NCT00006269 | Terminated Phase 3

• 2 other identifiers: CDR0000068215NOVARTIS-CSMS995US05
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer; Diarrhea

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; diarrhea

Interventions

irinotecan hydrochloride DRUG

octreotide acetate DRUG

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey, 07936, United States

Location

Theradex

Princeton, New Jersey, 08543, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Diarrhea; Colonic Neoplasms; Rectal Neoplasms

Interventions

Irinotecan; Octreotide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kurt Sizer, MD

  Novartis Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: SUPPORTIVE CARE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: May 24, 2004
• Study Start: December 1, 1999
• Primary Completion: December 1, 1999
• Last Updated: May 25, 2012

Record last verified: 2012-05

Locations

US (2)