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

Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme

Phase 1

Withdrawn

Conditions: Glioblastoma Multiforme

Interventions: Drug: BCNU Wafer
Drug: Irinotecan
Drug: Bevacizumab

First Posted Date: 2009-09-25

Last Posted Date: 2019-11-25

Lead Sponsor: University of Cincinnati

Registration Number: NCT00984438

Locations: 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States

HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver

Phase 1

Completed

Conditions: Liver Cancer
Advanced Cancer

Interventions: Drug: Irinotecan
Drug: Bevacizumab
Drug: Oxaliplatin
Drug: Cetuximab

First Posted Date: 2009-09-21

Last Posted Date: 2015-11-11

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 115

Registration Number: NCT00980239

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer

Phase 3

Active, not recruiting

Conditions: PRETEXT IV Hepatoblastoma
PRETEXT II Hepatoblastoma
PRETEXT III Hepatoblastoma
PRETEXT I Hepatoblastoma

Interventions: Drug: Cisplatin
Procedure: Therapeutic Conventional Surgery
Drug: Doxorubicin Hydrochloride
Drug: Dexrazoxane
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Procedure: Liver Transplantation
Drug: Temsirolimus
Drug: Vincristine Sulfate

First Posted Date: 2009-09-21

Last Posted Date: 2025-01-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 236

Registration Number: NCT00980460

Locations: 🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
Michigan State University Clinical Center, East Lansing, Michigan, United States
🇺🇸
Hurley Medical Center, Flint, Michigan, United States

and more 206 locations

Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme

Phase 2

Completed

Conditions: Glioblastoma Multiforme
Gliosarcoma

Interventions: Drug: Avastin
Drug: Temozolomide
Drug: Irinotecan

First Posted Date: 2009-09-17

Last Posted Date: 2014-03-19

Lead Sponsor: Katy Peters

Target Recruit Count: 41

Registration Number: NCT00979017

Locations: 🇺🇸
The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, Durham, North Carolina, United States

Study of Tumor Tissue Testing in Selecting Treatment for Patients With Metastatic or Locally Advanced Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

First Posted Date: 2009-09-14

Last Posted Date: 2013-12-19

Lead Sponsor: Medical Research Council

Target Recruit Count: 3240

Registration Number: NCT00975897

Locations: 🇬🇧
Belfast City Hospital Trust Incorporating Belvoir Park Hospital, Belfast, Northern Ireland, United Kingdom
🇬🇧
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
🇬🇧
Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom

Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Phase 1

Completed

Conditions: Rectal Cancer

First Posted Date: 2009-09-09

Last Posted Date: 2017-10-25

Lead Sponsor: University College, London

Target Recruit Count: 82

Registration Number: NCT00972881

Locations: 🇬🇧
Cancer Research UK and University College London Cancer Trials Centre, Rhyl, Denbighshire, Wales, United Kingdom
🇬🇧
Yorkshire Regional Clinical Trials & Research Unit, Leeds, England, United Kingdom
🇬🇧
Christie Hospital, Manchester, England, United Kingdom

and more 2 locations

CS-1008 Used With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Treatment With Oxaliplatin

Phase 2

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: CS-1008
Drug: irinotecan

First Posted Date: 2009-08-31

Last Posted Date: 2012-01-31

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 8

Registration Number: NCT00969033

Locations: 🇬🇧
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
🇬🇧
Clatterbridge Hospital, Bebington, Wirral, United Kingdom
🇬🇧
Nottingham City Hospital, Nottingham, Notts, United Kingdom

and more 6 locations

Capecitabine, Panitumumab, and Radiation Therapy With or Without Irinotecan Hydrochloride in Treating Patients Undergoing Surgery for Localized Rectal Cancer

Phase 2

Conditions: Colorectal Cancer

First Posted Date: 2009-08-28

Last Posted Date: 2014-01-10

Lead Sponsor: Loma Linda Oncology Medical Group, Inc.

Target Recruit Count: 54

Registration Number: NCT00967655

Locations: 🇺🇸
New Hope Cancer and Research Institute - Pomona, Redlands, California, United States
🇺🇸
New Hope Cancer and Research Institute - Glendora, Redlands, California, United States
🇺🇸
Davood Vafai, MD, Medical Offices, Incorporated, Redlands, California, United States

and more 1 locations