MedPath

Irinotecan

Generic Name
Irinotecan
Brand Names
Camptosar, Onivyde, Onivyde pegylated liposomal (previously known as Onivyde)
Drug Type
Small Molecule
Chemical Formula
C33H38N4O6
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
-

Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma

Phase 3
Active, not recruiting
Conditions
Alveolar Rhabdomyosarcoma
Botryoid-Type Embryonal Rhabdomyosarcoma
Embryonal Rhabdomyosarcoma
Sclerosing Rhabdomyosarcoma
Rhabdomyosarcoma
Spindle Cell Rhabdomyosarcoma
Interventions
Drug: Cyclophosphamide
Biological: Dactinomycin
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
Drug: Temsirolimus
Drug: Vinorelbine
First Posted Date
2015-10-05
Last Posted Date
2024-12-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
325
Registration Number
NCT02567435
Locations
🇺🇸

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States

🇺🇸

Atrium Health Navicent, Macon, Georgia, United States

🇺🇸

Springfield Memorial Hospital, Springfield, Illinois, United States

and more 383 locations

Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)

Phase 3
Completed
Conditions
Esophageal Carcinoma
Esophagogastric Junction Carcinoma
Interventions
First Posted Date
2015-09-30
Last Posted Date
2023-03-13
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
628
Registration Number
NCT02564263

S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Phase 2
Completed
Conditions
Pancreatic Adenocarcinoma
Resectable Pancreatic Carcinoma
Interventions
First Posted Date
2015-09-29
Last Posted Date
2022-10-19
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
147
Registration Number
NCT02562716
Locations
🇺🇸

Emory University Hospital Midtown, Atlanta, Georgia, United States

🇺🇸

Licking Memorial Hospital, Newark, Ohio, United States

🇺🇸

Geisinger Medical Group, State College, Pennsylvania, United States

and more 802 locations

Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer

Phase 2
Completed
Conditions
Biliary Tract Neoplasms
Interventions
First Posted Date
2015-09-24
Last Posted Date
2018-02-13
Lead Sponsor
Zhejiang University
Target Recruit Count
64
Registration Number
NCT02558959
Locations
🇨🇳

First affiliated hospital, Zhejiang University, Hangzhou, Zhejiang, China

Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer

Phase 2
Completed
Conditions
Pancreatic Neoplasms
Interventions
First Posted Date
2015-09-24
Last Posted Date
2018-06-21
Lead Sponsor
Zhejiang University
Target Recruit Count
80
Registration Number
NCT02558868
Locations
🇨🇳

First affiliated hospital, Zhejiang University, Hangzhou, Zhejiang, China

A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

Phase 3
Completed
Conditions
Pancreatic Cancer
Carcinoma
Interventions
First Posted Date
2015-09-03
Last Posted Date
2024-01-09
Lead Sponsor
UNICANCER
Target Recruit Count
171
Registration Number
NCT02539537
Locations
🇫🇷

Hôpital Trousseau, Chambray-les-tours, France

🇫🇷

Hôpital Avicenne, Bobigny, France

🇫🇷

CHU Amiens - Hôpital Nord, Amiens, France

and more 42 locations

A Study of FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab

Phase 2
Conditions
Colorectal Cancer
Interventions
First Posted Date
2015-08-05
Last Posted Date
2015-08-05
Lead Sponsor
Japan Clinical Cancer Research Organization
Target Recruit Count
360
Registration Number
NCT02515734

A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma

Phase 2
Completed
Conditions
Ewing's Sarcoma
Interventions
First Posted Date
2015-07-29
Last Posted Date
2022-12-22
Lead Sponsor
Gradalis, Inc.
Target Recruit Count
22
Registration Number
NCT02511132
Locations
🇺🇸

Mary Crowley Cancer Research Centers, Dallas, Texas, United States

🇺🇸

Arkansas Children's Hospital, Little Rock, Arkansas, United States

🇺🇸

Nicklaus Children's Hospital (Miami Children's Health System), Miami, Florida, United States

and more 3 locations

FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer

Phase 2
Terminated
Conditions
Recurrent Colorectal Carcinoma
Stage IVA Colorectal Cancer
Stage IVB Colorectal Cancer
Interventions
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Biological: Panitumumab
First Posted Date
2015-07-24
Last Posted Date
2018-08-16
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
1
Registration Number
NCT02508077
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

🇺🇸

City of Hope Antelope Valley, Lancaster, California, United States

🇺🇸

City of Hope Rancho Cucamonga, Rancho Cucamonga, California, United States

and more 1 locations

RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)

Phase 2
Completed
Conditions
Carcinoma, Non-Small-Cell Lung
Neuroendocrine Tumors
Small Cell Carcinoma
Ovarian Epithelial Cancer
Interventions
First Posted Date
2015-07-03
Last Posted Date
2022-10-03
Lead Sponsor
EpicentRx, Inc.
Target Recruit Count
139
Registration Number
NCT02489903
Locations
🇺🇸

Stanford University, Palo Alto, California, United States

🇺🇸

Baptist Health, Lexington, Kentucky, United States

🇺🇸

Memorial Hospital of South Bend, South Bend, Indiana, United States

and more 7 locations
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