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

Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma

Phase 2

Active, not recruiting

Conditions: Newly Diagnosed Ewing Sarcoma

Interventions: Drug: Cyclophosphamide
Device: Doxorubicin
Drug: Vincristine
Drug: Ifosfamide
Drug: Etoposide
Procedure: Surgery
Radiation: Radiation Therapy*
Drug: Temozolomide
Drug: Irinotecan
Drug: Mesna
Drug: Dexrazoxane
Drug: G-CSF

First Posted Date: 2013-05-29

Last Posted Date: 2024-11-12

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 83

Registration Number: NCT01864109

Locations: 🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 4 locations

Phase I/II Trial of Antagonism of HER in GI Cancer

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer
Recurrent Colorectal Cancer

Interventions: Drug: AZD8931
Drug: Irinotecan
Drug: Folinic Acid
Drug: Fluorouracil

First Posted Date: 2013-05-24

Last Posted Date: 2019-08-19

Lead Sponsor: University College, London

Target Recruit Count: 24

Registration Number: NCT01862003

Locations: 🇬🇧
University College London Hospital NHS Foundation Trust, London, United Kingdom
🇬🇧
The Christie NHS Foundation Trust, Manchester, United Kingdom
🇬🇧
Barts Health NHS Trust, London, United Kingdom

and more 1 locations

Effect of Curcumin on Dose Limiting Toxicity and Pharmacokinetics of Irinotecan in Patients With Solid Tumors

Phase 1

Completed

Conditions: Advanced Colorectal Cancer

Interventions: Dietary Supplement: curcumin
Drug: Irinotecan

First Posted Date: 2013-05-22

Last Posted Date: 2023-12-04

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 23

Registration Number: NCT01859858

Locations: 🇺🇸
IU Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
University of North Carolina at Chapel Hill Lineberger Comprehensive cancer Center, Chapel Hill, North Carolina, United States

GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer

Phase 2

Conditions: Biliary Cancer

Interventions: Drug: Irinotecan
Drug: Cisplatin
Drug: Gemcitabine

First Posted Date: 2013-05-22

Last Posted Date: 2018-01-18

Lead Sponsor: Hospital de Cancer de Barretos - Fundacao Pio XII

Target Recruit Count: 48

Registration Number: NCT01859728

Locations: 🇧🇷
Barretos Cancer Hospital, Barretos, SP, Brazil

Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Treatment Combining Cetuximab With FOLFOX or FOLFIRI in RAS and B-RAF WT Tumors

Phase 2

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Procedure: Metastases Resection ( multiple steep surgery possible)
Drug: 5-Fluorouracile
Drug: leucovorin L
Drug: Oxaliplatin
Drug: Irinotecan
Drug: Cetuximab

First Posted Date: 2013-05-21

Last Posted Date: 2016-04-15

Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Target Recruit Count: 4

Registration Number: NCT01858662

Locations: 🇧🇪
CHU-UCL Dinant-Godinne, Yvoir, Belgium
🇧🇪
clinique Saint Luc, Bouge, Belgium
🇧🇪
Cliniques universitaires Saint-Luc - UCL, Brussels, Belgium

and more 4 locations

Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Bevacizumab With FOLFOX or FOLFIRI.

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Procedure: Metastases resection
Drug: Bevacizumab
Drug: 5 FU
Drug: Oxaliplatin
Drug: Irinotecan

First Posted Date: 2013-05-21

Last Posted Date: 2020-10-22

Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Target Recruit Count: 60

Registration Number: NCT01858649

Locations: 🇧🇪
Clinique Saint Luc, Bouge, Belgium
🇧🇪
AZ Groeninge, Kortrijk, Belgium
🇧🇪
CHU-UCL Dinant-Godinne, Yvoir, Belgium

and more 8 locations

Phase I Study of Olaparib and Temozolomide for Ewings Sarcoma or Rhabdoomyosarcoma

Phase 1

Active, not recruiting

Conditions: Ewing Sarcoma
Rhabdomyosarcoma

Interventions: Drug: Olaparib
Drug: Temozolomide
Drug: Irinotecan

First Posted Date: 2013-05-21

Last Posted Date: 2024-03-12

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 93

Registration Number: NCT01858168

Locations: 🇺🇸
St. Jude's Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 2 locations

Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis

Not Applicable

Withdrawn

Conditions: Colorectal Cancer

Interventions: Drug: Irinotecan
Radiation: CyberKnife

First Posted Date: 2013-05-07

Last Posted Date: 2024-10-04

Lead Sponsor: Wake Forest University Health Sciences

Registration Number: NCT01847495

Locations: 🇺🇸
Advocate Lutheran General Hospital, Park Ridge, Illinois, United States

A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas

Phase 1

Completed

Conditions: Optic Nerve Glioma
Low-grade Glioma
Pilocytic Astrocytoma
Pilomyxoid Astrocytoma
Glioma, Astrocytic
Pleomorphic Xanthoastrocytoma
Anaplastic Astrocytoma
Diffuse Intrinsic Pontine Glioma
Glioblastoma Multiforme
DIPG

Interventions: Drug: Mebendazole
Drug: Bevacizumab
Drug: Vincristine
Drug: Carboplatin
Drug: Irinotecan
Drug: Temozolomide

First Posted Date: 2013-04-23

Last Posted Date: 2024-07-05

Lead Sponsor: Julie Krystal

Target Recruit Count: 36

Registration Number: NCT01837862

Locations: 🇺🇸
Cohen Children's Medical Center of New York, New Hyde Park, New York, United States

CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer

Phase 1

Completed

Conditions: Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer

Interventions: Drug: 6,8-bis(benzylthio)octanoic acid
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: irinotecan hydrochloride
Drug: fluorouracil
Other: laboratory biomarker analysis

First Posted Date: 2013-04-18

Last Posted Date: 2023-07-12

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 21

Registration Number: NCT01835041

Locations: 🇺🇸
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States

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