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

Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma

Phase 2

Completed

Conditions: Pancreatic Adenocarcinoma

Interventions: Drug: Capecitabine
Drug: Oxaliplatin
Drug: Irinotecan

First Posted Date: 2012-03-20

Last Posted Date: 2017-05-09

Lead Sponsor: The University of Hong Kong

Target Recruit Count: 37

Registration Number: NCT01558869

Locations: 🇭🇰
Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong

Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA

Phase 1

Terminated

Conditions: Stage IV Colorectal Cancer

Interventions: Drug: Ascorbic Acid
Drug: Irinotecan

First Posted Date: 2012-03-12

Last Posted Date: 2020-07-13

Lead Sponsor: Thomas Jefferson University

Target Recruit Count: 4

Registration Number: NCT01550510

Locations: 🇺🇸
Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Metformin in Children With Relapsed or Refractory Solid Tumors

Phase 1

Completed

Conditions: Primary Brain Tumors
Solid Tumors

Interventions: Drug: Vincristine
Drug: Irinotecan
Drug: Temozolomide
Drug: Metformin

First Posted Date: 2012-02-07

Last Posted Date: 2023-01-13

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

Target Recruit Count: 26

Registration Number: NCT01528046

Locations: 🇺🇸
Primary Children's Medical Center/Utah, Salt Lake City, Utah, United States
🇺🇸
Nemours Children's Clinic, Jacksonville, Florida, United States
🇺🇸
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

and more 11 locations

Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With Solid Tumors

Phase 1

Completed

Conditions: Neuroblastoma
Rhabdomyosarcoma and Other Soft Tissue Sarcomas
Ewing's Sarcoma Family of Tumors
Osteosarcoma
Brain Tumors

Interventions: Drug: sorafenib
Drug: irinotecan

First Posted Date: 2012-01-26

Last Posted Date: 2015-02-27

Lead Sponsor: HMeany

Target Recruit Count: 17

Registration Number: NCT01518413

Locations: 🇺🇸
National Cancer Institute, Bethesda, Maryland, United States
🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Children's Hospital Boston/Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 1 locations

Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma

Phase 1

Terminated

Conditions: Neuroblastoma

Interventions: Drug: TPI 287
Drug: Temozolomide
Drug: Irinotecan

First Posted Date: 2012-01-06

Last Posted Date: 2024-08-06

Lead Sponsor: Giselle Sholler

Target Recruit Count: 14

Registration Number: NCT01505608

Locations: 🇺🇸
Rady Children's Hospital, San Diego, California, United States
🇺🇸
Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States
🇺🇸
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

and more 5 locations

S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

Phase 2

Completed

Conditions: Esophageal Cancer
Adenocarcinoma of the Gastroesophageal Junction
Gastric Cancer

Interventions: Drug: FOLFOX regimen
Drug: docetaxel
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin

First Posted Date: 2011-12-23

Last Posted Date: 2019-11-07

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 213

Registration Number: NCT01498289

Locations: 🇺🇸
Memorial Hospital, Carthage, Illinois, United States
🇺🇸
Altru Cancer Center, Grand Forks, North Dakota, United States
🇺🇸
Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States

and more 501 locations

Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer

Phase 2

Conditions: Biliary Tract Cancer

First Posted Date: 2011-12-19

Last Posted Date: 2011-12-19

Lead Sponsor: Soon Chun Hyang University

Target Recruit Count: 53

Registration Number: NCT01494363

Locations: 🇰🇷
Nam Su Lee, Seoul, Korea, Republic of
🇰🇷
Han Jo Kim, Cheonan, Korea, Republic of
🇰🇷
Hyun Jung Kim, Bucheon, Korea, Republic of

Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: Placebo to match SIM
Biological: Simtuzumab
Drug: Leucovorin
Drug: Irinotecan
Drug: Fluorouracil

First Posted Date: 2011-11-24

Last Posted Date: 2019-04-17

Lead Sponsor: Gilead Sciences

Target Recruit Count: 266

Registration Number: NCT01479465

Locations: 🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸
West Michigan Cancer Center, Kalamazoo, Michigan, United States
🇺🇸
Providence Saint Joseph Medical Center-Disney Family Cancer Center, Burbank, California, United States

and more 100 locations