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

Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma

Phase 2

Completed

Conditions: Rectal Carcinoma

Interventions: Drug: 5FU
Radiation: Radiation
Procedure: Surgery of resectable lesions
Drug: Irinotecan

First Posted Date: 2008-05-22

Last Posted Date: 2017-10-06

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 135

Registration Number: NCT00682786

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

Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: Irinotecan
Drug: Avastin
Drug: Erbitux

First Posted Date: 2008-05-21

Last Posted Date: 2013-02-13

Lead Sponsor: Hellenic Oncology Research Group

Target Recruit Count: 16

Registration Number: NCT00681876

Locations: 🇬🇷
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology, Thessaloniki, Greece
🇬🇷
: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece
🇬🇷
401 Military Hospital of Athens, Athens, Greece

and more 5 locations

Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme: Phase I

Phase 1

Terminated

Conditions: Malignant Gliomas

Interventions: Drug: Irinotecan
Drug: Lenalidomide

First Posted Date: 2008-05-05

Last Posted Date: 2018-11-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT00671801

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

A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer

Interventions: Drug: cetuximab
Drug: FOLFIRI regimen
Drug: dulanermin
Drug: bevacizumab
Drug: irinotecan

First Posted Date: 2008-05-05

Last Posted Date: 2016-11-02

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 42

Registration Number: NCT00671372

Panitumumab and Irinotecan as Third-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Panitumumab
Drug: Irinotecan hydrochloride
Genetic: Chromogenic in situ hybridization
Genetic: Fluorescence in situ hybridization
Genetic: Gene expression analysis
Other: Laboratory biomarker analysis

First Posted Date: 2008-04-10

Last Posted Date: 2021-09-21

Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Target Recruit Count: 65

Registration Number: NCT00655499

Locations: 🇫🇷
Hopital Clinique Claude Bernard, Metz, France
🇫🇷
Hopital Prive Jean Mermoz, Lyon, France
🇫🇷
Centre Hospitalier Intercommunal Le Raincy - Montfermeil, Montfermeil, France

and more 6 locations

Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Gastrointestinal Cancer

Phase 1

Completed

Conditions: Extrahepatic Bile Duct Cancer
Anal Cancer
Carcinoma of the Appendix
Gastric Cancer
Gastrointestinal Carcinoid Tumor
Esophageal Cancer
Gallbladder Cancer
Gastrointestinal Stromal Tumor
Liver Cancer
Pancreatic Cancer

First Posted Date: 2008-04-07

Last Posted Date: 2017-05-25

Lead Sponsor: Mayo Clinic

Target Recruit Count: 7

Registration Number: NCT00654160

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.

Phase 3

Completed

Conditions: Colorectal Cancer

Interventions: Drug: bevacizumab [Avastin]
Drug: irinotecan
Drug: leucovorin
Drug: fluorouracil

First Posted Date: 2008-03-25

Last Posted Date: 2022-12-22

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 214

Registration Number: NCT00642577

A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: capecitabine [Xeloda]
Drug: bevacizumab [Avastin]
Drug: oxaliplatin
Drug: irinotecan

First Posted Date: 2008-03-25

Last Posted Date: 2018-03-29

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 41

Registration Number: NCT00642603

Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)

Phase 2

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Erlotinib
Drug: Fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin
Drug: Irinotecan

First Posted Date: 2008-03-25

Last Posted Date: 2014-09-26

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 16

Registration Number: NCT00642746

Locations: 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States

Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Phase 2

Completed

Conditions: Head and Neck Cancer

Interventions: Drug: cisplatin
Drug: irinotecan hydrochloride

First Posted Date: 2008-03-20

Last Posted Date: 2012-09-14

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 41

Registration Number: NCT00639769

Locations: 🇺🇸
Meharry Medical College, Nashville, Tennessee, United States
🇺🇸
VA Tennessee Valley Healthcare Center, Nashville, Tennessee, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

and more 5 locations

Drug Development Updates

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