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

Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors

Phase 1

Completed

Conditions: Central Nervous System Tumors

Interventions: Drug: Bevacizumab
Drug: Irinotecan
Drug: Temozolomide

First Posted Date: 2009-04-07

Last Posted Date: 2023-07-03

Lead Sponsor: Johns Hopkins All Children's Hospital

Target Recruit Count: 26

Registration Number: NCT00876993

Locations: 🇺🇸
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States

A Study of TS-1 Plus Irinotecan and Cisplatin (IP) for Patients With Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

Phase 1

Conditions: Advanced Non-Small Cell Lung Cancer

Interventions: Drug: Irinotecan
Drug: Cisplatin
Drug: TS-1 (S-1)

First Posted Date: 2009-04-02

Last Posted Date: 2010-10-25

Lead Sponsor: National Cancer Center, Korea

Target Recruit Count: 74

Registration Number: NCT00874328

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer

Phase 2

Completed

Conditions: Gastric Cancer
Stomach Cancer

Interventions: Drug: Cetuximab
Drug: Irinotecan
Drug: Cisplatin
Procedure: Surgery
Drug: 5-FU
Radiation: Radiation

First Posted Date: 2009-03-06

Last Posted Date: 2015-12-07

Lead Sponsor: NYU Langone Health

Target Recruit Count: 30

Registration Number: NCT00857246

Locations: 🇺🇸
NYU Cancer Center, New York, New York, United States

NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: NKTR-102
Drug: irinotecan

First Posted Date: 2009-03-05

Last Posted Date: 2021-07-12

Lead Sponsor: Nektar Therapeutics

Target Recruit Count: 83

Registration Number: NCT00856375

Locations: 🇮🇳
Investigator Site - Ahmedabad, Ahmedabad, Gujarat, India
🇮🇳
Investigator Site - Kochi, Kochi, Kerata, India
🇺🇸
Investigator Site - Burbank, Burbank, California, United States

and more 19 locations

Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer (CRC)

Interventions: Drug: Irinotecan
Drug: 5-Fluorouracil (bolus)
Drug: 5-Fluorouracil (infusional)
Drug: Leucovorin calcium
Drug: CT-322
Drug: Bevacizumab
Drug: Bevacizumab Placebo (saline solution)

First Posted Date: 2009-02-25

Last Posted Date: 2015-10-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 17

Registration Number: NCT00851045

Locations: 🇺🇸
Midwest Center For Hematology/Oncology, Joliet, Illinois, United States
🇺🇸
Pharma Resource, East Providence, Rhode Island, United States
🇺🇸
Compassionate Cancer Care Medical Group Inc, Fountain Valley, California, United States

and more 10 locations

Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers

Phase 2

Terminated

Conditions: Gastric Cancer
Esophageal Cancer
Gastric Adenocarcinoma

Interventions: Drug: Irinotecan
Drug: Cisplatin
Procedure: Surgery
Drug: Floxuridine
Drug: Capecitabine

First Posted Date: 2009-02-20

Last Posted Date: 2018-01-08

Lead Sponsor: NYU Langone Health

Target Recruit Count: 8

Registration Number: NCT00848783

Locations: 🇺🇸
Bellevue Hospital, New York, New York, United States
🇺🇸
NYU Cancer Center, New York, New York, United States
🇺🇸
Norris Cancer Center, Los Angeles, California, United States

A Study of Irinotecan and Cetuximab With or Without IMC-A12 for Treatment of Participants With Colon or Rectum Cancer Who Got Worse After Their First Treatment With Oxaliplatin and Bevacizumab

Phase 2

Terminated

Conditions: Colon Cancer
Rectal Cancer

Interventions: Biological: Cetuximab
Drug: Irinotecan
Biological: IMC-A12 (cixutumumab)

First Posted Date: 2009-02-16

Last Posted Date: 2018-07-02

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 4

Registration Number: NCT00845039

Locations: 🇺🇸
ImClone Investigational Site, Scranton, Pennsylvania, United States

Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

Phase 1

Terminated

Conditions: Colorectal Cancer

Interventions: Biological: KRN330
Drug: Irinotecan

First Posted Date: 2009-02-06

Last Posted Date: 2024-04-26

Lead Sponsor: Kyowa Kirin Co., Ltd.

Target Recruit Count: 65

Registration Number: NCT00838578

Locations: 🇺🇸
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Greater Baltimore Medical Center, Baltimore, Maryland, United States
🇺🇸
University of Florida COllege of Medicine/Shands Cancer Center, Gainesville, Florida, United States

and more 9 locations