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

Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors

Phase 1

Completed

Conditions: Ganglioglioma
Astrocytoma, Oligoastrocytoma, Mixed
Ganglioneuroma
Glioblastoma Multiforme Glioma
Glioma

Interventions: Drug: Irinotecan
Drug: Bevacizumab
Device: FDOPA-PET/MRI imaging

First Posted Date: 2013-12-03

Last Posted Date: 2016-10-21

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 6

Registration Number: NCT01999270

Locations: 🇺🇸
Washington University School of Medicine, St. Louis, Missouri, United States

Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer

Phase 2

Conditions: Small Cell Lung Carcinoma

Interventions: Drug: Irinotecan
Drug: Cisplatin

First Posted Date: 2013-11-06

Last Posted Date: 2016-04-01

Lead Sponsor: Third Military Medical University

Target Recruit Count: 110

Registration Number: NCT01977235

Locations: 🇨🇳
Xinqiao Hospital, Third Military Medical University, Chongqing, Chongqing, China
🇨🇳
Xinan Hospital, Third Military Medical University, Chongqing, Chongqing, China
🇨🇳
Chongqing Cancer Hospital, Chongqing, Chongqing, China

Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: First Line Metastatic Colorectal Cancer

Interventions: Drug: Irinotecan

First Posted Date: 2013-10-16

Last Posted Date: 2019-12-26

Lead Sponsor: Centre Jean Perrin

Target Recruit Count: 47

Registration Number: NCT01963182

Locations: 🇫🇷
Clinique de la Châtaigneraie, Beaumont, France
🇫🇷
Centre Jean Perrin, Clermont-Ferrand, France
🇫🇷
CHU Estaing, Clermont-Ferrand, France

S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer

Phase 1

Completed

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: Oxaliplatin
Drug: PEGPH20
Drug: Leucovorin
Drug: Irinotecan
Drug: 5-fluorouracil

First Posted Date: 2013-10-09

Last Posted Date: 2024-02-09

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 126

Registration Number: NCT01959139

Locations: 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
UC Irvine Health Cancer Center-Newport, Costa Mesa, California, United States
🇺🇸
Palo Alto Medical Foundation-Camino Division, Mountain View, California, United States

and more 150 locations

Short-Infusion Ziv-aflibercept in Treating Patients With Metastatic Colorectal Cancer Receiving Combination Chemotherapy

Not Applicable

Withdrawn

Conditions: Stage IVB Colon Cancer
Recurrent Rectal Cancer
Stage IVB Rectal Cancer
Recurrent Colon Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer

Interventions: Biological: ziv-aflibercept
Drug: leucovorin calcium
Drug: irinotecan hydrochloride
Drug: fluorouracil

First Posted Date: 2013-09-13

Last Posted Date: 2014-07-21

Lead Sponsor: City of Hope Medical Center

Registration Number: NCT01941173

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
City of Hope- South Pasadena Cancer Center, South Pasadena, California, United States
🇺🇸
City of Hope Antelope Valley, Lancaster, California, United States

Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients

Phase 1

Completed

Conditions: Non Small Cell Lung Carcinoma
Small Cell Lung Carcinoma
Irinotecan Sensitive Cancers

Interventions: Drug: Carfilzomib
Drug: Irinotecan

First Posted Date: 2013-09-13

Last Posted Date: 2024-05-09

Lead Sponsor: Cancer Research and Biostatistics Clinical Trials Consortium

Target Recruit Count: 78

Registration Number: NCT01941316

Locations: 🇺🇸
Virginia Mason Cancer Institute, Seattle, Washington, United States
🇺🇸
Aurora Research Institute | Aurora Cancer Care, Wauwatosa, Wisconsin, United States
🇺🇸
Cancer Treatment Centers of America, Western Regional Medical Center, Goodyear, Arizona, United States

and more 5 locations

A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases

Not Applicable

Withdrawn

Conditions: Central Nervous System Metastases
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer

Interventions: Drug: irinotecan hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2013-09-11

Last Posted Date: 2014-10-08

Lead Sponsor: University of California, Irvine

Registration Number: NCT01939483

Azacitidine and Entinostat Before Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Phase 2

Terminated

Conditions: Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
Stage IIIA Non-Small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer

Interventions: Drug: Azacitidine
Drug: Docetaxel
Drug: Entinostat
Drug: Gemcitabine Hydrochloride
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Pemetrexed Disodium

First Posted Date: 2013-09-05

Last Posted Date: 2018-07-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT01935947

Locations: 🇺🇸
USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States
🇺🇸
Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

and more 2 locations