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 Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors

Phase 1

Terminated

Conditions: Neoplasms

Interventions: Drug: RG1507
Drug: RO1507
Drug: erlotinib [Tarceva]
Drug: bevacizumab [Avastin]
Drug: pemetrexel
Drug: carboplatin
Drug: capecitabine [Xeloda]
Drug: sorafenib
Drug: temozolomide
Drug: cetuximab
Drug: paclitaxel
Drug: etoposide
Drug: mFOLFOX6
Drug: trastuzumab [Herceptin]
Drug: docetaxel
Drug: gemcitabine
Drug: irinotecan

First Posted Date: 2008-12-19

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 104

Registration Number: NCT00811993

Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma

Phase 2

Terminated

Conditions: Neuroblastoma

Interventions: Drug: Temsirolimus
Drug: Irinotecan
Procedure: Surgical Resection of Primary Tumor
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Etoposide
Drug: Cisplatin
Drug: Topotecan
Procedure: PBSC
Radiation: Radiation Therapy
Drug: 13-cis-retinoic acid

First Posted Date: 2008-12-16

Last Posted Date: 2017-05-30

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 4

Registration Number: NCT00808899

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

Bevacizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

Phase 3

Conditions: Colorectal Cancer

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

First Posted Date: 2008-11-25

Last Posted Date: 2013-08-26

Lead Sponsor: Southern Italy Cooperative Oncology Group

Target Recruit Count: 672

Registration Number: NCT00797485

Locations: 🇮🇹
Southern Italy Cooperative Oncology Group, Naples, Italy

Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

First Posted Date: 2008-11-17

Last Posted Date: 2012-06-13

Lead Sponsor: Vejle Hospital

Target Recruit Count: 32

Registration Number: NCT00792363

Locations: 🇩🇰
Vejle Hospital, Dept. of Oncology, Vejle, Denmark

A Pilot Study of the Addition of Bevacizumab to VOIT Regimen for Relapsed/Refractory Pediatric Solid Tumors

Phase 1

Completed

Conditions: Solid Tumor

Interventions: Drug: Bevacizumab
Drug: Temozolomide
Drug: Vincristine
Drug: Irinotecan
Drug: Cefixime

First Posted Date: 2008-11-06

Last Posted Date: 2021-02-10

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Target Recruit Count: 13

Registration Number: NCT00786669

Locations: 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: 5-FU
Drug: Irinotecan
Drug: Leucovorin
Drug: Oxaliplatin
Drug: bevacizumab [Avastin]

First Posted Date: 2008-10-23

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 80

Registration Number: NCT00778102

Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Mets to Liver

Phase 2

Withdrawn

Conditions: Colon Cancer
Colorectal Cancer

Interventions: Drug: SIR-spheres Agent Administration
Drug: Cetuximab
Drug: Irinotecan

First Posted Date: 2008-10-03

Last Posted Date: 2013-01-03

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT00766220

A Phase I Trial of Vorinostat in Combination With Bevacizumab & Irinotecan in Recurrent Glioblastoma

Phase 1

Completed

Conditions: Glioblastoma

Interventions: Drug: Vorinostat
Drug: Bevacizumab
Drug: Irinotecan

First Posted Date: 2008-09-30

Last Posted Date: 2013-07-25

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 19

Registration Number: NCT00762255

Locations: 🇺🇸
H. Lee Moffitt Cancer Center & Research Institute, Inc., Tampa, Florida, United States

Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: Irinotecan
Drug: Capecitabine
Drug: Cetuximab
Drug: Oxaliplatin

First Posted Date: 2008-09-19

Last Posted Date: 2013-02-13

Lead Sponsor: Hellenic Oncology Research Group

Target Recruit Count: 68

Registration Number: NCT00755534

Locations: 🇬🇷
University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece
🇬🇷
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece
🇬🇷
University Hospital of Heraklion, Dep of Medical Oncology, Heraklion, Creta, Greece

and more 7 locations

Lohp, 5-Fu/Lv and Bevacizumab, Alternative With Cpt-11, 5-Fu/Lv and Cetuximab In Metastatic Crc

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: Oxaliplatin
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Bevacizumab
Drug: Irinotecan
Drug: Cetuximab

First Posted Date: 2008-09-18

Last Posted Date: 2015-10-07

Lead Sponsor: University Hospital of Crete

Target Recruit Count: 24

Registration Number: NCT00755118

Locations: 🇬🇷
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece
🇬🇷
University Hospital of Crete, Dep of Medical Oncology, Heraklion, Crete, Greece
🇬🇷
University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece

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