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

A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Neoplasms

Interventions: Drug: KD018
Drug: Placebo
Drug: Irinotecan

First Posted Date: 2008-08-08

Last Posted Date: 2019-05-22

Lead Sponsor: Edward Chu, MD

Target Recruit Count: 33

Registration Number: NCT00730158

Locations: 🇺🇸
Yale University Comprehensive Cancer Center, New Haven, Connecticut, United States
🇺🇸
Hillman CancerCenters, Pittsburgh, Pennsylvania, United States

Irinotecan in Treating Asian Patients With Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: irinotecan hydrochloride
Other: pharmacogenomic studies
Other: pharmacological study

First Posted Date: 2008-08-08

Last Posted Date: 2017-03-31

Lead Sponsor: National Cancer Centre, Singapore

Target Recruit Count: 18

Registration Number: NCT00731276

Locations: 🇸🇬
National Cancer Centre - Singapore, Singapore, Singapore

Second-Line Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer Who Have Received First-Line Chemotherapy and Bevacizumab

Phase 3

Terminated

Conditions: Colorectal Cancer

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

First Posted Date: 2008-07-22

Last Posted Date: 2015-03-11

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 184

Registration Number: NCT00720512

Locations: 🇮🇹
Ospedale Santa Croce, Cuneo, Italy
🇮🇹
Ospedale degli Infermi - ASL 12, Biella, Italy
🇮🇹
Azienda Usl 8 Arezzo, Arezzo, Italy

and more 18 locations

Combination Chemotherapy and Bevacizumab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Phase 3

Completed

Conditions: Colorectal Cancer

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

First Posted Date: 2008-07-22

Last Posted Date: 2015-03-11

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 509

Registration Number: NCT00719797

Locations: 🇮🇹
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona - Ancona (An) Oncologia Medica, Ancona, Italy
🇮🇹
P.O. Zona Aretina - Ospedale S. Donato Di Arezzo - Arezzo (Ar) Oncologia Medica, Arezzo, Italy
🇮🇹
Ospedale Della Valdinievole - Pescia (Pt) Oncologia Medica, Pescia, Italy

and more 41 locations

Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies

Phase 1

Completed

Conditions: Non-Hodgkins Lymphoma
Hodgkin's Disease
Acute Lymphoblastic Leukemia

Interventions: Drug: Dexamethasone
Drug: Irinotecan
Drug: Vincristine

First Posted Date: 2008-07-21

Last Posted Date: 2013-08-28

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 4

Registration Number: NCT00718757

Locations: 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
Rady's Children Hospital San Diego, San Diego, California, United States

Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment

Phase 2

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Capecitabine
Drug: Bevacizumab
Drug: Irinotecan

First Posted Date: 2008-07-18

Last Posted Date: 2015-10-07

Lead Sponsor: University Hospital of Crete

Target Recruit Count: 15

Registration Number: NCT00717990

Locations: 🇬🇷
University Hospital of Crete, Dep of Medical Oncology, Heraklion, Greece

Genotype-Directed Dose-Escalation Study of Irinotecan in Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Advanced Cancer

Interventions: Drug: Irinotecan

First Posted Date: 2008-07-02

Last Posted Date: 2017-01-04

Lead Sponsor: University of Chicago

Target Recruit Count: 68

Registration Number: NCT00708773

Locations: 🇺🇸
NorthShore University HealthSystem, Evanston, Illinois, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States

Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer

Phase 2

Completed

Conditions: Small Cell Lung Cancer

Interventions: Drug: irinotecan
Drug: Carboplatin
Drug: sunitinib

First Posted Date: 2008-06-11

Last Posted Date: 2021-11-22

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 37

Registration Number: NCT00695292

Locations: 🇺🇸
Oncology Hematology Care, Cincinnati, Ohio, United States
🇺🇸
Florida Hospital Cancer Insitute, Orlando, Florida, United States
🇺🇸
Northeast Georgia Medical Center, Gainesville, Georgia, United States

and more 7 locations