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

Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma

Phase 2

Completed

Conditions: Untreated Childhood Rhabdomyosarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Embryonal Rhabdomyosarcoma
Adult Rhabdomyosarcoma
Metastatic Childhood Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma

Interventions: Biological: Cixutumumab
Biological: Dactinomycin
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Doxorubicin Hydrochloride
Drug: Ifosfamide
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Temozolomide
Drug: Vincristine Sulfate Liposome

First Posted Date: 2010-01-25

Last Posted Date: 2017-08-29

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 175

Registration Number: NCT01055314

Locations: 🇺🇸
Seattle Children's Hospital, Seattle, Washington, United States
🇺🇸
Riley Hospital for Children, Indianapolis, Indiana, United States
🇺🇸
Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, United States

and more 136 locations

Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI)

Phase 1

Completed

Conditions: Gastro-Intestinal Cancer

Interventions: Drug: 5-FU
Drug: Leucovorin
Drug: Irinotecan
Drug: Brivanib

First Posted Date: 2010-01-12

Last Posted Date: 2014-09-16

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 49

Registration Number: NCT01046864

Locations: 🇺🇸
Scott & White Memorial Hospital And Clinic, Temple, Texas, United States
🇺🇸
Texas Oncology, Dallas, Texas, United States
🇺🇸
Usc/Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 1 locations

An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors

Completed

Conditions: Cervical Cancer
Non-small Cell Lung Cancer
Ovarian Cancer
Gastric Cancer (Inoperable and Recurrent)
Small Cell Lung Cancer

Interventions: Drug: CPT-11
Drug: Platinum analogues

First Posted Date: 2009-12-29

Last Posted Date: 2019-05-23

Lead Sponsor: Daiichi Sankyo Co., Ltd.

Target Recruit Count: 321

Registration Number: NCT01040312

Locations: 🇯🇵
Department of Obstetrics and Gynecology, National Defense Medical College Hospital, Tokorozawa, Japan

Panitumumab and Irinotecan for Malignant Gliomas

Phase 2

Terminated

Conditions: Malignant Glioma of Brain

Interventions: Drug: Irinotecan
Drug: Panitumumab

First Posted Date: 2009-11-20

Last Posted Date: 2013-09-04

Lead Sponsor: Annick Desjardins

Target Recruit Count: 16

Registration Number: NCT01017653

Locations: 🇺🇸
The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, Durham, North Carolina, United States

OSI-906 and Irinotecan in Patients With Advanced Cancer

Phase 1

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: OSI-906
Drug: irinotecan

First Posted Date: 2009-11-20

Last Posted Date: 2013-10-21

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 16

Registration Number: NCT01016860

Locations: 🇺🇸
University of Colorado Denver, Aurora, Colorado, United States

Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

Phase 3

Terminated

Conditions: Choroid Plexus Tumors
Brain Cancer

Interventions: Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Cisplatin
Drug: Etoposide
Drug: Vincristine
Drug: Dactinomycin
Drug: Leucovorin
Drug: Irinotecan
Drug: Doxorubicin
Drug: Methotrexate
Drug: Temozolomide

First Posted Date: 2009-11-17

Last Posted Date: 2019-08-20

Lead Sponsor: Tufts Medical Center

Target Recruit Count: 27

Registration Number: NCT01014767

Locations: 🇳🇿
Christchurch Hospital, Christchurch, New Zealand
🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States
🇭🇺
Semmelweis University, Budapest, Hungary

and more 2 locations

EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: EMD 525797 250 mg
Drug: EMD 525797 500 mg
Drug: EMD 525797 750 mg
Drug: EMD 525797 1000 mg
Drug: Cetuximab
Drug: Irinotecan

First Posted Date: 2009-11-05

Last Posted Date: 2016-03-30

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Target Recruit Count: 232

Registration Number: NCT01008475

Locations: 🇬🇧
Research Site, Sutton, United Kingdom
🇷🇺
Research, Arkhangelsk, Russian Federation
🇩🇪
Research site, Hannover, Germany

A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin

Phase 1

Completed

Conditions: Refractory Solid Tumors in Children

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

First Posted Date: 2009-10-09

Last Posted Date: 2023-10-06

Lead Sponsor: Children's Hospital Los Angeles

Target Recruit Count: 13

Registration Number: NCT00993044

Locations: 🇺🇸
Childrens Hospital los Angeles, Los Angeles, California, United States

Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery

Phase 2

Completed

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Diffuse Adenocarcinoma of the Stomach
Intestinal Adenocarcinoma of the Stomach
Mixed Adenocarcinoma of the Stomach
Recurrent Gastric Cancer
Stage IIIA Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIC Gastric Cancer
Stage IV Gastric Cancer

Interventions: Drug: alvocidib
Drug: irinotecan hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2009-10-08

Last Posted Date: 2014-05-26

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 19

Registration Number: NCT00991952

Locations: 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States
🇺🇸
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

and more 2 locations

A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)

Phase 1

Completed

Conditions: Pediatric Solid Tumors

Interventions: Drug: Irinotecan
Drug: Carboplatin

First Posted Date: 2009-10-07

Last Posted Date: 2010-02-05

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 20

Registration Number: NCT00990912

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