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 camptothe...

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 fluo...

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

Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors

Phase 1

Completed

Conditions: Neuroblastoma
Brain and Central Nervous System Tumors

First Posted Date: 2003-04-30

Last Posted Date: 2015-04-23

Lead Sponsor: Darell D. Bigner, MD, PhD

Target Recruit Count: 21

Registration Number: NCT00003484

Locations: 🇺🇸
Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Phase 2

Completed

Conditions: Extensive Stage Small Cell Lung Cancer

Interventions: Biological: G-CSF
Drug: Cisplatin
Drug: Irinotecan
Drug: Etoposide
Drug: Topotecan

First Posted Date: 2003-04-09

Last Posted Date: 2023-07-05

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 140

Registration Number: NCT00057837

Locations: 🇺🇸
Elkhart General Hospital, Elkhart, Indiana, United States
🇺🇸
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
🇺🇸
St. Luke's Regional Medical Center, Sioux City, Iowa, United States

and more 75 locations

A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid Tumors

Phase 2

Completed

Conditions: Neoplasms

Interventions: Drug: carboplatin + irinotecan
Drug: irinotecan

First Posted Date: 2003-04-03

Last Posted Date: 2011-04-14

Lead Sponsor: Bristol-Myers Squibb

Registration Number: NCT00057473

Locations: 🇺🇸
Local Institution, Houston, Texas, United States

S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Phase 2

Terminated

Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer

Interventions: Drug: irinotecan

First Posted Date: 2003-02-06

Last Posted Date: 2013-11-08

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 2

Registration Number: NCT00053833

Locations: 🇺🇸
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
🇺🇸
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
🇺🇸
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States

and more 97 locations

Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2003-02-06

Last Posted Date: 2014-01-13

Lead Sponsor: Roswell Park Cancer Institute

Registration Number: NCT00054288

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia

Phase 1

Completed

Conditions: Leukemia

First Posted Date: 2003-01-28

Last Posted Date: 2011-03-08

Lead Sponsor: Roswell Park Cancer Institute

Registration Number: NCT00053144

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Irinotecan in Treating Children With Refractory Solid Tumors

Phase 2

Completed

Conditions: Childhood Central Nervous System Germ Cell Tumor
Childhood Choroid Plexus Tumor
Childhood Craniopharyngioma
Childhood Grade I Meningioma
Childhood Grade II Meningioma
Childhood Grade III Meningioma
Childhood Infratentorial Ependymoma
Childhood Oligodendroglioma
Childhood Supratentorial Ependymoma
Previously Treated Childhood Rhabdomyosarcoma

Interventions: Drug: irinotecan hydrochloride

First Posted Date: 2003-01-28

Last Posted Date: 2013-06-14

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 181

Registration Number: NCT00004078

Locations: 🇺🇸
Children's Oncology Group, Arcadia, California, United States

S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

Phase 3

Completed

Conditions: Lung Cancer

Interventions: Drug: cisplatin
Drug: irinotecan hydrochloride
Drug: etoposide

First Posted Date: 2003-01-27

Last Posted Date: 2018-07-31

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 671

Registration Number: NCT00045162

Locations: 🇺🇸
Northside Hospital Cancer Center, Atlanta, Georgia, United States
🇺🇸
Saint Joseph's Hospital of Atlanta, Atlanta, Georgia, United States
🇺🇸
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States

and more 399 locations

7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007)

Phase 1

Completed

Conditions: Advanced Adult Primary Liver Cancer
Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Recurrent Gastric Cancer
Recurrent Gastrointestinal Carcinoid Tumor
Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
Carcinoma of the Appendix
Gastrointestinal Stromal Tumor
Estrogen Receptor-negative Breast Cancer

Interventions: Drug: 7-hydroxystaurosporine
Drug: irinotecan hydrochloride
Other: diagnostic laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-09-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 41

Registration Number: NCT00031681

Locations: 🇺🇸
University of Virginia, Charlottesville, Virginia, United States

Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

Phase 3

Completed

Conditions: Colorectal Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-12-19

Lead Sponsor: Sanofi

Registration Number: NCT00012389

Locations: 🇺🇸
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
🇺🇸
Hematology Oncology Consultants Inc, Columbus, Ohio, United States

and more 149 locations

Drug Development Updates

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