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

Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer

Phase 2

Completed

Conditions: Stomach Neoplasms
Esophageal Neoplasms

Interventions: Drug: Irinotecan
Drug: Oxaliplatin
Drug: Trastuzumab
Drug: Leucovorin
Drug: Fluorouracil

First Posted Date: 2013-08-23

Last Posted Date: 2020-08-25

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 67

Registration Number: NCT01928290

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

Phase 3

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Oxaliplatin
Drug: Irinotecan
Drug: Leucovorin
Drug: 5FU
Radiation: Stereotactic Body Radiotherapy (SBRT)

First Posted Date: 2013-08-20

Last Posted Date: 2022-10-28

Lead Sponsor: Stanford University

Target Recruit Count: 27

Registration Number: NCT01926197

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
🇺🇸
Loyola University, Maywood, Illinois, United States
🇺🇸
Swedish Cancer Institute, Seattle, Washington, United States

and more 6 locations

A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: PF-05212384
Drug: Cetuximab
Drug: Irinotecan

First Posted Date: 2013-08-19

Last Posted Date: 2019-01-08

Lead Sponsor: Pfizer

Target Recruit Count: 19

Registration Number: NCT01925274

Locations: 🇺🇸
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
🇺🇸
Siteman Cancer Center - St Peters, Saint Peters, Missouri, United States
🇺🇸
Kadlec Medical Center, Richland, Washington, United States

and more 25 locations

Irinotecan and Alisertib in Treating Patients With Advanced Solid Tumors or Colorectal Cancer

Phase 1

Completed

Conditions: Recurrent Rectal Cancer
Signet Ring Adenocarcinoma of the Colon
Signet Ring Adenocarcinoma of the Rectum
Unspecified Adult Solid Tumor, Protocol Specific
Recurrent Colon Cancer
Mucinous Adenocarcinoma of the Colon
Mucinous Adenocarcinoma of the Rectum
Stage IIIA Colon Cancer

Interventions: Drug: irinotecan hydrochloride
Drug: alisertib

First Posted Date: 2013-08-15

Last Posted Date: 2019-01-04

Lead Sponsor: University of California, Davis

Target Recruit Count: 17

Registration Number: NCT01923337

Locations: 🇺🇸
UC Davis Comprehensive Cancer Center, Sacramento, California, United States

A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.

Phase 1

Completed

Conditions: Advanced Gastrointestinal Tumors

Interventions: Drug: TAS-102
Drug: CPT-11
Drug: Bevacizumab

First Posted Date: 2013-08-05

Last Posted Date: 2024-06-27

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 65

Registration Number: NCT01916447

Locations: 🇺🇸
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
Chicago Clinical Site, Chicago, Illinois, United States
🇺🇸
Los Angeles Clinical Site, Los Angeles, California, United States

and more 1 locations

Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer

Phase 2

Terminated

Conditions: Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer

Interventions: Drug: Fluorouracil
Drug: Gemcitabine Hydrochloride
Radiation: Intensity-Modulated Radiation Therapy
Drug: Irinotecan Hydrochloride
Drug: Leucovorin Calcium
Drug: Oxaliplatin

First Posted Date: 2013-07-12

Last Posted Date: 2023-12-05

Lead Sponsor: Albert Einstein College of Medicine

Target Recruit Count: 23

Registration Number: NCT01897454

Locations: 🇺🇸
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States

Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Previously Treated Metastatic Colorectal Cancer

Interventions: Drug: SGI-110 Dose Escalation
Drug: Regorafenib
Drug: Irinotecan
Drug: TAS-102
Drug: SGI-110

First Posted Date: 2013-07-11

Last Posted Date: 2020-10-06

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 118

Registration Number: NCT01896856

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 1 locations

A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan

Phase 2

Completed

Conditions: Colorectal Cancer Metastatic

Interventions: Drug: Aflibercept
Drug: Levofolinate
Drug: Irinotecan
Drug: 5-FU

First Posted Date: 2013-06-20

Last Posted Date: 2017-03-14

Lead Sponsor: Sanofi

Target Recruit Count: 62

Registration Number: NCT01882868

Locations: 🇯🇵
Investigational Site Number 392002, Sunto-Gun, Japan
🇯🇵
Investigational Site Number 392005, Suita-Shi, Japan
🇯🇵
Investigational Site Number 392017, Fukuoka-Shi, Japan

and more 16 locations

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Phase 2

Active, not recruiting

Conditions: Rhabdomyosarcoma

Interventions: Drug: Vincristine
Drug: Dactinomycin
Drug: Cyclophosphamide
Procedure: Surgical Resection
Procedure: Radiation
Drug: Myeloid Growth Factor
Drug: Bevacizumab
Procedure: Lymph Node Sampling
Drug: Sorafenib
Drug: ^1^1C-methionine
Drug: Irinotecan
Drug: Ifosfamide
Drug: Etoposide
Drug: Etoposide Phosphate
Drug: Doxorubicin
Drug: Dexrazoxane

First Posted Date: 2013-06-07

Last Posted Date: 2024-08-09

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 98

Registration Number: NCT01871766

Locations: 🇺🇸
Nemours Children's Clinic, Jacksonville, Florida, United States
🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
University of Florida Proton Therapy Institute, Jacksonville, Florida, United States

and more 1 locations

Nordic 8 - A Phase II Trial

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Cetuximab
Drug: Irinotecan
Drug: Folinic Acid
Drug: Oxaliplatin
Drug: Calcium Carbonate

First Posted Date: 2013-06-04

Last Posted Date: 2020-10-30

Lead Sponsor: Per Pfeiffer

Target Recruit Count: 173

Registration Number: NCT01867697

Locations: 🇩🇰
Rigshospitalet, Copenhagen, Denmark
🇩🇰
Sydvestjysk Hospital, Esbjerg, Denmark
🇩🇰
Odense University Hospital, Odense, Denmark

and more 9 locations

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