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Last Updated: May 29, 2020

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CLINICAL TRIALS PROFILE FOR IRINOTECAN HYDROCHLORIDE

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505(b)(2) Clinical Trials for Irinotecan Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00177853 Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer Terminated Pharmacia and Upjohn Phase 1 2006-12-01 The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
New Combination NCT00177853 Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer Terminated University of Pittsburgh Phase 1 2006-12-01 The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
New Combination NCT00215982 Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer Completed Roche Pharma AG Phase 2 2004-12-01 The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination NCT00215982 Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer Completed H. Lee Moffitt Cancer Center and Research Institute Phase 2 2004-12-01 The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination NCT00230399 Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer Completed University of Michigan Cancer Center Phase 2 2003-06-01 This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
New Combination NCT00876993 Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors Completed V Foundation Phase 1 2008-09-01 Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.
New Combination NCT00876993 Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors Completed Johns Hopkins All Children's Hospital Phase 1 2008-09-01 Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Irinotecan Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001495 A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors Completed National Cancer Institute (NCI) Phase 1 1995-11-01 This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.
NCT00002759 Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma Completed National Cancer Institute (NCI) Phase 1 1996-06-01 Phase I trial to study the effectiveness of irinotecan plus cyclosporine and phenobarbital in treating patients who have solid tumors or lymphoma that is refractory to standard therapy. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Cyclosporine and phenobarbital may enhance the effectiveness of irinotecan.
NCT00002902 Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors Completed National Cancer Institute (NCI) Phase 1 1997-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating patients with advanced solid tumors.
NCT00002902 Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors Completed University of Pennsylvania Phase 1 1997-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating patients with advanced solid tumors.
NCT00002933 Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer Completed National Cancer Institute (NCI) Phase 2 1996-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent colorectal cancer.
NCT00002933 Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer Completed Case Comprehensive Cancer Center Phase 2 1996-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent colorectal cancer.
NCT00002939 Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer Completed National Cancer Institute (NCI) Phase 1 1996-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Irinotecan Hydrochloride

Condition Name

Condition Name for Irinotecan Hydrochloride
Intervention Trials
Colorectal Cancer 234
Metastatic Colorectal Cancer 120
Gastric Cancer 59
Pancreatic Cancer 52
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Condition MeSH

Condition MeSH for Irinotecan Hydrochloride
Intervention Trials
Colorectal Neoplasms 502
Adenocarcinoma 135
Pancreatic Neoplasms 116
Stomach Neoplasms 96
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Clinical Trial Locations for Irinotecan Hydrochloride

Trials by Country

Trials by Country for Irinotecan Hydrochloride
Location Trials
United States 3,504
Canada 227
China 153
Japan 142
Italy 136
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Trials by US State

Trials by US State for Irinotecan Hydrochloride
Location Trials
California 193
New York 187
Texas 139
Illinois 131
Ohio 124
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Clinical Trial Progress for Irinotecan Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Irinotecan Hydrochloride
Clinical Trial Phase Trials
Phase 4 10
Phase 3 134
Phase 2/Phase 3 23
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Clinical Trial Status

Clinical Trial Status for Irinotecan Hydrochloride
Clinical Trial Phase Trials
Completed 518
Recruiting 260
Not yet recruiting 128
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Clinical Trial Sponsors for Irinotecan Hydrochloride

Sponsor Name

Sponsor Name for Irinotecan Hydrochloride
Sponsor Trials
National Cancer Institute (NCI) 273
Pfizer 46
Amgen 32
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Sponsor Type

Sponsor Type for Irinotecan Hydrochloride
Sponsor Trials
Other 1188
Industry 561
NIH 281
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