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

Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer

Phase 4

Recruiting

Conditions: Stage IIIA Esophageal Adenocarcinoma
Esophageal Adenocarcinoma
Stage IIIC Gastric Cancer
Gastric Adenocarcinoma
Stage IIIB Esophageal Adenocarcinoma
Stage IIIC Esophageal Adenocarcinoma
Stage IIB Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIA Gastric Cancer

Interventions: Drug: Oxaliplatin
Drug: Leucovorin Calcium
Drug: Irinotecan Hydrochloride
Drug: Fluorouracil
Procedure: Conventional Surgery

First Posted Date: 2015-02-19

Last Posted Date: 2024-05-02

Lead Sponsor: University of Chicago

Target Recruit Count: 36

Registration Number: NCT02366819

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Kellogg Cancer Center - Evanston Hospital, Evanston, Illinois, United States
🇺🇸
NorthShore University HealthSystem, Evanston, Illinois, United States

Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer

Phase 4

Conditions: Small Cell Lung Cancer

Interventions: Drug: Etoposide
Drug: Irinotecan
Drug: Cisplatin

First Posted Date: 2015-01-28

Last Posted Date: 2016-12-05

Lead Sponsor: Guangdong Association of Clinical Trials

Target Recruit Count: 308

Registration Number: NCT02348450

Locations: 🇨🇳
WuHan Tongji Hospital, WuHan, Hubei, China
🇨🇳
LiaoNing Provincial Tumor Hospital, Shenyang, Liaoning, China
🇨🇳
The second affiliated hospital of zhejiang university school of medicine, Hangzhou, Zhejiang, China

and more 17 locations

Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study

Phase 2

Terminated

Conditions: Pancreatic Adenocarcinoma
Stage IA Pancreatic Cancer
Poorly Differentiated Malignant Neoplasm
Stage IIB Pancreatic Cancer
Stage III Pancreatic Cancer
Undifferentiated Pancreatic Carcinoma
Resectable Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer

Interventions: Drug: Irinotecan Hydrochloride
Drug: Oxaliplatin
Drug: Leucovorin Calcium
Drug: Fluorouracil
Other: Laboratory Biomarker Analysis

First Posted Date: 2015-01-26

Last Posted Date: 2018-07-13

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 1

Registration Number: NCT02345460

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Folfoxiri Plus Bev Followed by Reintroduction of Folfoxiri Plus Bev at Progression Versus Folfox Plus Bev Followed by Folfiri Plus Bev in mCRC

Phase 3

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: fluoruracil
Drug: Oxaliplatin
Drug: Irinotecan
Drug: Bevacizumab

First Posted Date: 2015-01-15

Last Posted Date: 2020-02-05

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 654

Registration Number: NCT02339116

Locations: 🇮🇹
Polo Oncologico - AOUP, Pisa, PI, Italy

Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer

Phase 1

Completed

Conditions: Adenocarcinoma of Unknown Primary
Adult Cholangiocarcinoma
Gallbladder Carcinoma
Malignant Gastrointestinal Neoplasm
Metastatic Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma
Gastric Adenocarcinoma
Stage III Ampulla of Vater Cancer
Stage III Pancreatic Cancer
Stage IIIA Gallbladder Cancer

Interventions: Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Drug: Leucovorin Calcium
Drug: Irinotecan Hydrochloride
Drug: Fluorouracil
Other: Laboratory Biomarker Analysis

First Posted Date: 2015-01-07

Last Posted Date: 2023-05-31

Lead Sponsor: University of Chicago

Target Recruit Count: 50

Registration Number: NCT02333188

Locations: 🇺🇸
Ingalls Memorial Hospital, Harvey, Illinois, United States
🇺🇸
Indiana University Medical Center, Indianapolis, Indiana, United States
🇺🇸
Virginia Mason, Seattle, Washington, United States

and more 5 locations

Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)

Phase 1

Terminated

Conditions: Pancreatic Cancer
Small Cell Lung Cancer
Ovarian
Sarcoma
Advanced Cancer
Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Gemcitabine
Drug: Liposomal Doxorubicin
Drug: Irinotecan
Drug: Docetaxel
Drug: Nab-paclitaxel
Drug: Vinorelbine

First Posted Date: 2015-01-06

Last Posted Date: 2018-07-02

Lead Sponsor: Western Regional Medical Center

Target Recruit Count: 81

Registration Number: NCT02331251

Locations: 🇺🇸
Cancer Treatment Center of America @ Western Regional Medical Center, Goodyear, Arizona, United States
🇺🇸
Western Regional Medical Center, Goodyear, Arizona, United States

A Study MLN2480 in Combination With MLN0128 or Alisertib, or Paclitaxel, or Cetuximab, or Irinotecan in Adult Participants With Advanced Nonhematologic Malignancies

Phase 1

Completed

Conditions: Advanced Nonhematologic Malignancies

Interventions: Drug: MLN2480
Drug: MLN0128
Drug: Alisertib
Drug: Paclitaxel
Drug: Cetuximab
Drug: Irinotecan

First Posted Date: 2014-12-30

Last Posted Date: 2020-02-25

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 81

Registration Number: NCT02327169

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 11 locations

Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer

Phase 1

Completed

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: Gemcitabine
Drug: Taxotere
Drug: Xeloda
Drug: Cisplatin
Drug: Irinotecan

First Posted Date: 2014-12-24

Last Posted Date: 2023-07-21

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 47

Registration Number: NCT02324543

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial

Phase 3

Conditions: Esophageal Neoplasms

Interventions: Drug: S-1
Drug: S1
Drug: irinotecan

First Posted Date: 2014-12-18

Last Posted Date: 2015-08-03

Lead Sponsor: Chinese Academy of Medical Sciences

Target Recruit Count: 240

Registration Number: NCT02319187

Locations: 🇨🇳
Hunan Cancer Hospital,the Affiliated Cancer Hospital of Xianya School of Medicine, Changsha, China
🇨🇳
Herbin Medical University Cancer Hospital, Herbin, China
🇨🇳
Henan Cancer Hospital, Zhengzhou, China

and more 10 locations

Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study

Phase 2

Terminated

Conditions: Colorectal Cancer Metastatic

Interventions: Drug: cetuximab
Drug: Irinotecan

First Posted Date: 2014-12-15

Last Posted Date: 2017-08-01

Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Target Recruit Count: 2

Registration Number: NCT02316496

Locations: 🇫🇷
Hôpital Saint Louis, Paris, France
🇫🇷
Hôpital Pitié Salpêtrière, Paris, France
🇫🇷
Hôpital Européeen, Marseille, France

and more 17 locations

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