Irinotecan

Generic Name: Irinotecan

Brand Names: Camptosar, Onivyde, Onivyde pegylated liposomal (previously known as Onivyde)

Drug Type: Small Molecule

Chemical Formula: C_₃₃H_₃₈N_₄O_₆

CAS Number: 97682-44-5

Unique Ingredient Identifier: 7673326042

Background: Irinotecan is an antineoplastic enzyme inhibitor primarily used in the treatment of colorectal cancer. It is a derivative of camptothecin that inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex, and causes double-strand DNA breakage and cell death. It is a derivative of camptothecin. Irinotecan was approved for the treatment of advanced pancreatic cancer in October, 2015 (irinotecan liposome injection, trade name Onivyde).

Indication: For the treatment of metastatic colorectal cancer (first-line therapy when administered with 5-fluorouracil and leucovorin). Also used in combination with cisplatin for the treatment of extensive small cell lung cancer. Irinotecan is currently under investigation for the treatment of metastatic or recurrent cervical cancer. Also used in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

Associated Conditions: Esophageal Cancer, Ewing's Sarcoma, Gastric Cancer, High Grade Glioma: Glioblastoma (GBM), Metastatic Cervical Cancer, Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer, Pancreatic Cancer, Rhabdomyosarcomas, Small Cell Lung Cancer (SCLC), Stage IV Colorectal Cancer, Recurrent, metastatic Colorectal carcinoma, Refractory, metastatic Pancreatic adenocarcinoma

Associated Therapies: -

Clinical Trials

Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Drug: irinotecan hydrochloride
Drug: fluorouracil
Drug: leucovorin calcium
Drug: Oxaliplatin

First Posted Date: 2004-12-09

Last Posted Date: 2023-07-05

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 247

Registration Number: NCT00098787

Locations: 🇺🇸
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
🇺🇸
St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States
🇺🇸
Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States

and more 107 locations

Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

Interventions: Drug: irinotecan hydrochloride
Drug: temozolomide
Procedure: adjuvant therapy
Radiation: radiation therapy

First Posted Date: 2004-12-09

Last Posted Date: 2014-01-24

Lead Sponsor: Radiation Therapy Oncology Group

Target Recruit Count: 170

Registration Number: NCT00099125

Locations: 🇺🇸
Cancer Center at St. Clair Memorial Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸
Providence Holy Cross Cancer Center, Mission Hills, California, United States
🇺🇸
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States

and more 115 locations

N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

Phase 1

Completed

Conditions: Diarrhea
Drug/Agent Toxicity by Tissue/Organ
Neuroblastoma

First Posted Date: 2004-10-08

Last Posted Date: 2010-10-15

Lead Sponsor: Children's Hospital Los Angeles

Target Recruit Count: 30

Registration Number: NCT00093353

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Indiana University Cancer Center, Indianapolis, Indiana, United States

and more 10 locations

Combination Chemotherapy in Treating Patients With Metastatic Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2004-09-14

Last Posted Date: 2013-05-30

Lead Sponsor: San Antonio Cancer Institute

Registration Number: NCT00003711

Locations: 🇺🇸
San Antonio Cancer Institute, San Antonio, Texas, United States
🇺🇸
Brooke Army Medical Center, Fort Sam Houston, Texas, United States

Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer

Phase 1

Completed

Conditions: Colorectal Cancer

First Posted Date: 2004-09-13

Last Posted Date: 2018-05-16

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 49

Registration Number: NCT00003344

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

Phase 3

Conditions: Colorectal Cancer

First Posted Date: 2004-09-09

Last Posted Date: 2009-02-09

Lead Sponsor: Federation Francophone de Cancerologie Digestive

Target Recruit Count: 1976

Registration Number: NCT00091312

Locations: 🇫🇷
Centre Hospitalier Universitaire Ambroise Pare - Boulogne, Boulogne Billancourt, France
🇪🇬
National Cancer Institute - Cairo, Cairo, Egypt
🇵🇹
Instituto Portugues de Oncologia Centro do Porto, S. A., Porto, Portugal

and more 6 locations

Irinotecan in Treating Patients With Recurrent Glioma

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

Interventions: Drug: irinotecan hydrochloride

First Posted Date: 2004-09-06

Last Posted Date: 2016-12-07

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 64

Registration Number: NCT00003134

Locations: 🇺🇸
Siouxland Hematology-Oncology, Sioux City, Iowa, United States
🇺🇸
CCOP - Geisinger Clinical and Medical Center, Danville, Pennsylvania, United States
🇺🇸
CCOP - Duluth, Duluth, Minnesota, United States

and more 16 locations

Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer

Phase 3

Conditions: Colorectal Cancer

First Posted Date: 2004-08-25

Last Posted Date: 2009-01-13

Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Target Recruit Count: 109

Registration Number: NCT00003260

Locations: 🇫🇷
Hopital Saint Antoine, Paris, France

Irinotecan in Treating Patients With Metastatic or Recurrent Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

First Posted Date: 2004-08-20

Last Posted Date: 2012-06-06

Lead Sponsor: Northwestern University

Registration Number: NCT00004182

Locations: 🇺🇸
Stanford University Medical Center, Stanford, California, United States
🇺🇸
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

First Posted Date: 2004-08-12

Last Posted Date: 2020-07-27

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 21

Registration Number: NCT00002933

Locations: 🇺🇸
Veterans Affairs Medical Center - Cleveland, Cleveland, Ohio, United States
🇺🇸
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Drug Development Updates

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