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

Study of IRNEA (Irinotecan, Etoposide, Cytarabine) for Refractory or Relapsed Acute Leukemia in Children and Adolescents

Phase 1

Conditions: Acute Leukemia

Interventions: Drug: Irinotecan

First Posted Date: 2010-11-11

Last Posted Date: 2013-11-19

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 18

Registration Number: NCT01239485

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Chongno-gu, Korea, Republic of

FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Panitumumab
Drug: Oxaliplatin
Drug: Irinotecan
Drug: Leucovorin
Drug: 5-Fluorouracil

First Posted Date: 2010-10-22

Last Posted Date: 2015-05-27

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 15

Registration Number: NCT01226719

Locations: 🇺🇸
Florida Hospital Cancer Institute, Orlando, Florida, United States
🇺🇸
Northeast Georgia Medical Center, Gainesville, Georgia, United States
🇺🇸
Hope Cancer Center, Terre Haute, Indiana, United States

and more 11 locations

Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Cetuximab
Drug: Irinotecan
Drug: Oxaliplatin
Drug: UFT

First Posted Date: 2010-10-21

Last Posted Date: 2014-06-11

Lead Sponsor: The Christie NHS Foundation Trust

Target Recruit Count: 47

Registration Number: NCT01225744

Locations: 🇬🇧
The Christie NHS Foundation Trust, Manchester, United Kingdom
🇬🇧
North Wales Cancer Treatment Centre, Llansantffraid Glan Conwy, United Kingdom
🇬🇧
The Royal Marsden, London and Surrey, United Kingdom

Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy

Phase 3

Conditions: Gastric Cancer

Interventions: Drug: Paclitaxel
Drug: Irinotecan

First Posted Date: 2010-10-20

Last Posted Date: 2010-10-20

Lead Sponsor: Korean Cancer Study Group

Target Recruit Count: 518

Registration Number: NCT01224652

Locations: 🇰🇷
Yonsei University Gangnam Severance Hospital, Seoul, Korea, Republic of
🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

RSHF in Colorectal Cancer

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Radiation: Radiation
Drug: Irinotecan

First Posted Date: 2010-10-13

Last Posted Date: 2019-01-07

Lead Sponsor: Institut Cancerologie de l'Ouest

Target Recruit Count: 48

Registration Number: NCT01220063

Locations: 🇫🇷
Centre Oscar Lambret, Lille, France
🇫🇷
Centre hospitalier Lyon Sud, Lyon, France
🇫🇷
Hôpital la Source, Orléans, France

and more 3 locations

Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors

Phase 2

Completed

Conditions: Pineoblastoma
Recurrent Medulloblastoma
Refractory Peripheral Primitive Neuroectodermal Tumor
Recurrent Primitive Neuroectodermal Tumor
Refractory Medulloblastoma
Central Nervous System Neoplasm

Interventions: Biological: Bevacizumab
Drug: Irinotecan Hydrochloride
Drug: Temozolomide

First Posted Date: 2010-10-08

Last Posted Date: 2021-07-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 108

Registration Number: NCT01217437

Locations: 🇺🇸
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
🇺🇸
Loma Linda University Medical Center, Loma Linda, California, United States
🇺🇸
University of Illinois, Chicago, Illinois, United States

and more 155 locations

Irinotecan Hydrochloride, Fluorouracil, and Leucovorin Calcium With or Without Zibotentan in Treating Patients With Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

First Posted Date: 2010-09-20

Last Posted Date: 2014-07-08

Lead Sponsor: Cardiff University

Target Recruit Count: 111

Registration Number: NCT01205711

Locations: 🇬🇧
Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom
🇬🇧
Leicester Royal Infirmary, Leicester, England, United Kingdom
🇬🇧
Centre for Cancer Research and Cell Biology at Queen's University Belfast, Belfast, Northern Ireland, United Kingdom

and more 1 locations

Radiolabeled Monoclonal Antibody Therapy, Combination Chemotherapy, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Recurrent Rectal Cancer
Stage IV Rectal Cancer
Recurrent Colon Cancer
Stage IV Colon Cancer

Interventions: Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: fluorouracil
Biological: bevacizumab
Radiation: yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
Other: laboratory biomarker analysis

First Posted Date: 2010-09-20

Last Posted Date: 2015-06-08

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 3

Registration Number: NCT01205022

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

A Study in Second Line Metastatic Colorectal Cancer

Phase 3

Completed

Conditions: Colorectal Cancer

Interventions: Biological: Placebo
Biological: Ramucirumab
Drug: Irinotecan
Drug: Folinic Acid
Drug: 5-Fluorouracil

First Posted Date: 2010-08-18

Last Posted Date: 2019-09-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1072

Registration Number: NCT01183780

Locations: 🇨🇳
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Taipei, Taiwan

Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer

Phase 3

Terminated

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Biological: cetuximab
Drug: FOLFIRI regimen
Drug: FOLFOX regimen
Drug: capecitabine
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: mitomycin C
Procedure: therapeutic conventional surgery

First Posted Date: 2010-07-22

Last Posted Date: 2024-12-27

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 340

Registration Number: NCT01167725

Locations: 🇺🇸
St. Agnes Hospital Cancer Center, Baltimore, Maryland, United States
🇺🇸
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

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