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 Recurrent or Refractory Small Cell Lung Cancer

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride

First Posted Date: 2004-03-24

Last Posted Date: 2016-07-14

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 73

Registration Number: NCT00005972

Locations: 🇺🇸
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
🇺🇸
University of Chicago Cancer Research Center, Chicago, Illinois, United States
🇺🇸
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States

and more 47 locations

Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2004-03-15

Last Posted Date: 2013-06-21

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00003742

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis

Phase 1

Completed

Conditions: Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2004-03-12

Last Posted Date: 2013-03-21

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT00003368

Locations: 🇺🇸
University of Chicago Cancer Research Center, Chicago, Illinois, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States

and more 42 locations

Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: alvocidib
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride

First Posted Date: 2004-03-10

Last Posted Date: 2013-01-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT00079352

Locations: 🇺🇸
University of New Mexico, Albuquerque, New Mexico, United States

Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer

Phase 3

Completed

Conditions: Adenocarcinoma of the Colon
Stage III Colon Cancer

Interventions: Drug: irinotecan hydrochloride
Drug: Locally Directed Therapy
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: fluorouracil
Biological: cetuximab

First Posted Date: 2004-03-10

Last Posted Date: 2020-05-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 3397

Registration Number: NCT00079274

Locations: 🇺🇸
Franklin Square Hospital Center, Baltimore, Maryland, United States
🇺🇸
Hematology and Oncology Associates, Chicago, Illinois, United States
🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States

and more 872 locations

Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: docetaxel
Drug: irinotecan hydrochloride

First Posted Date: 2004-03-09

Last Posted Date: 2016-12-13

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 70

Registration Number: NCT00079118

Locations: 🇺🇸
Kenton Oncology, Incorporated, Kenton, Ohio, United States
🇺🇸
McDonough District Hospital, Macomb, Illinois, United States
🇺🇸
Hurley Medical Center, Flint, Michigan, United States

and more 156 locations

Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Phase 2

Conditions: Colorectal Cancer

First Posted Date: 2004-03-08

Last Posted Date: 2009-01-13

Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Registration Number: NCT00006115

Locations: 🇫🇷
Hopital Tenon, Paris, France
🇫🇷
Hopital Claude Gallien, Quincy Sous Senart, France
🇫🇷
Hopital Saint Antoine, Paris, France

and more 13 locations

SU5416, Irinotecan, and Cisplatin in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2004-03-05

Last Posted Date: 2013-01-31

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Registration Number: NCT00006000

Locations: 🇺🇸
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

Docetaxel and Irinotecan in Treating Patients With Advanced Cancer of the Esophagus or Stomach

Phase 2

Completed

Conditions: Gastric Cancer
Esophageal Cancer

Interventions: Drug: docetaxel
Drug: irinotecan hydrochloride

First Posted Date: 2004-03-03

Last Posted Date: 2016-07-14

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 47

Registration Number: NCT00004235

Locations: 🇺🇸
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
🇺🇸
Medcenter One Health System, Bismarck, North Dakota, United States
🇺🇸
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States

and more 16 locations

Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: irinotecan hydrochloride

First Posted Date: 2004-03-01

Last Posted Date: 2016-07-14

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 104

Registration Number: NCT00003351

Locations: 🇺🇸
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
🇺🇸
CCOP - Wichita, Wichita, Kansas, United States
🇺🇸
Siouxland Hematology-Oncology, Sioux City, Iowa, United States

and more 19 locations

Drug Development Updates

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