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

Radiation Therapy, Irinotecan, and Cetuximab in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Rectal Cancer

Phase 1

Conditions: Colorectal Cancer

First Posted Date: 2006-10-26

Last Posted Date: 2011-05-25

Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Target Recruit Count: 20

Registration Number: NCT00392470

Locations: 🇨🇭
Kantonsspital Aarau, Aarau, Switzerland
🇨🇭
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
🇨🇭
Institut Ludwig de Recherche sur le Cancer, Epalinges, Switzerland

Bevacizumab and Irinotecan to Treat Brain Tumors

Phase 2

Terminated

Conditions: High-Grade Gliomas

Interventions: Biological: Bevacizumab
Drug: Irinotecan hydrochloride

First Posted Date: 2006-10-26

Last Posted Date: 2012-07-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 31

Registration Number: NCT00393094

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Irinotecan With or Without Panitumumab or Cyclosporine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Fluorouracil

Phase 3

Completed

Conditions: Colorectal Cancer

First Posted Date: 2006-10-19

Last Posted Date: 2022-06-01

Lead Sponsor: University of Leeds

Target Recruit Count: 1198

Registration Number: NCT00389870

Locations: 🇬🇧
James Cook University Hospital, Middlesbrough, England, United Kingdom
🇬🇧
Royal Marsden - Surrey, Sutton, England, United Kingdom
🇬🇧
Clatterbridge Centre for Oncology, Merseyside, England, United Kingdom

and more 30 locations

Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Long-term Effects Secondary to Cancer Therapy in Children
Poor Performance Status
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Long-term Effects Secondary to Cancer Therapy in Adults

First Posted Date: 2006-10-19

Last Posted Date: 2017-11-06

Lead Sponsor: University of California, Davis

Target Recruit Count: 30

Registration Number: NCT00389584

Locations: 🇺🇸
University of California Davis Cancer Center, Sacramento, California, United States

Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: carboplatin
Drug: irinotecan

First Posted Date: 2006-10-13

Last Posted Date: 2018-01-10

Lead Sponsor: University of California, Davis

Target Recruit Count: 80

Registration Number: NCT00387660

Locations: 🇺🇸
University of California Davis Cancer Center, Sacramento, California, United States

Bevacizumab and Irinotecan in Treating Young Patients With Recurrent, Progressive, or Refractory Glioma, Medulloblastoma, Ependymoma, or Low Grade Glioma

Phase 2

Completed

Conditions: Childhood Spinal Cord Neoplasm
Childhood Cerebral Anaplastic Astrocytoma
Recurrent Childhood Brain Stem Glioma
Childhood Oligodendroglioma
Recurrent Childhood Ependymoma
Recurrent Childhood Medulloblastoma

Interventions: Biological: Bevacizumab
Radiation: Fludeoxyglucose F-18
Drug: Irinotecan Hydrochloride

First Posted Date: 2006-09-28

Last Posted Date: 2017-11-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 97

Registration Number: NCT00381797

Locations: 🇺🇸
Pediatric Brain Tumor Consortium, Memphis, Tennessee, United States
🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
Texas Children's Hospital, Houston, Texas, United States

and more 8 locations

Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX

Phase 2

Completed

Conditions: Colorectal Cancer
Nausea and Vomiting

Interventions: Drug: aprepitant
Drug: dexamethasone
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: palonosetron hydrochloride
Procedure: quality-of-life assessment

First Posted Date: 2006-09-28

Last Posted Date: 2017-06-12

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 54

Registration Number: NCT00381862

Locations: 🇺🇸
St. Josephs/Cander Hospital, Savannah, Georgia, United States
🇺🇸
Kaiser Permanente, Hilo, Hawaii, United States
🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

and more 3 locations

SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer

Phase 1

Terminated

Conditions: Colorectal Carcinoma

First Posted Date: 2006-08-08

Last Posted Date: 2017-02-17

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 6

Registration Number: NCT00361244

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

Phase 3

Completed

Conditions: Adult Rhabdomyosarcoma
Childhood Botryoid-Type Embryonal Rhabdomyosarcoma
Rhabdomyosarcoma
Sarcoma
Stage I Adult Soft Tissue Sarcoma AJCC v7
Stage III Adult Soft Tissue Sarcoma AJCC v7
Localized Childhood Soft Tissue Sarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Embryonal Rhabdomyosarcoma
Stage II Adult Soft Tissue Sarcoma AJCC v7

Interventions: Drug: Cyclophosphamide
Biological: Dactinomycin
Other: Laboratory Biomarker Analysis
Drug: Irinotecan Hydrochloride
Other: Questionnaire Administration
Radiation: Radiation Therapy
Drug: Vincristine Sulfate

First Posted Date: 2006-07-20

Last Posted Date: 2023-01-31

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 481

Registration Number: NCT00354835

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
🇺🇸
Kaiser Permanente Downey Medical Center, Downey, California, United States

and more 223 locations

Irinotecan, Cisplatin, Bevacizumab, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Esophageal Cancer

Phase 2

Completed

Conditions: Esophageal Cancer

Interventions: Biological: bevacizumab
Drug: cisplatin
Drug: irinotecan hydrochloride
Genetic: proteomic profiling
Other: diagnostic laboratory biomarker analysis
Other: mass spectrometry
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy

First Posted Date: 2006-07-20

Last Posted Date: 2016-05-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 34

Registration Number: NCT00354679

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

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