Clinical Trials Using Irinotecan Hydrochloride

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Irinotecan Hydrochloride. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 61
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  • FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients with Metastatic Pancreatic Cancer

    This randomized phase II trial studies how well modified irinotecan hydrochloride, leucovorin calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work compared to FOLFIRI in treating patients with pancreatic cancer that has come back after a period of improvement (metastatic). Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether modified FOLFIRI and veliparib as second line therapy is more effective than FOLFIRI alone in treating metastatic pancreatic cancer.
    Location: 788 locations

  • 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

    This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.
    Location: 793 locations

  • Risk-Based Therapy in Treating Younger Patients with Newly Diagnosed Liver Cancer

    This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.
    Location: 183 locations

  • Combination Chemotherapy with or without Hypofractionated Radiation Therapy before Surgery in Treating Patients with Pancreatic Cancer

    This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.
    Location: 101 locations

  • Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177 / KEYNOTE-177)

    In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) compared to current SOC chemotherapy.
    Location: 25 locations

  • ATR Kinase Inhibitor VX-970 and Irinotecan Hydrochloride in Treating Patients with Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

    This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or cannot be removed by surgery. ATR kinase inhibitor VX-970 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 17 locations

  • A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

    This is an international multi-center, prospective, open-label, randomized phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).
    Location: 16 locations

  • Metformin Hydrochloride, Vincristine Sulfate, Irinotecan Hydrochloride, and Temozolomide in Treating Younger Patients with Relapsed or Refractory Solid Tumors

    This phase I trial studies the side effects and best dose of metformin hydrochloride when given together with vincristine sulfate, irinotecan hydrochloride, and temozolomide in treating younger patients with solid tumors that have returned after a period of improvement (relapsed) or have not responded to previous treatment (refractory). Metformin hydrochloride may slow the growth of tumor cells and may be an effective treatment for solid tumors. Drugs used in chemotherapy, such as vincristine sulfate, irinotecan hydrochloride, and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving metformin hydrochloride together with vincristine sulfate, irinotecan hydrochloride, and temozolomide may kill more tumor cells.
    Location: 15 locations

  • I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

    The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
    Location: 14 locations

  • Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan / Cetuximab or Infusional 5-Fluorouracil (5-FU) / Folinic Acid (FA) / Irinotecan (FOLFIRI) / Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

    This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan / cetuximab or FOLFIRI / cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.
    Location: 12 locations

  • A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer

    The main purpose of this study is to evaluate the safety of different doses of olaratumab and to determine which dose should be used for future pediatric studies. The present study is open to children with advanced cancer or cancer that has spread to another part of the body. The study has two parts. In each part, a specific dose of olaratumab will be given for 21 days, followed by one of three standard chemotherapy regimens. Participants will only enroll in one part.
    Location: 9 locations

  • Genetic Testing in Determining Irinotecan Hydrochloride Dose in Patients with Metastatic Colorectal Cancer Receiving FOLFIRI and Bevacizumab

    This phase II trial studies how well genetic testing works in determining irinotecan hydrochloride dose in patients with colorectal cancer that has spread to other areas of the body, who are receiving leucovorin calcium, fluorouracil, and irinotecan hydrochloride (FOLFIRI) and bevacizumab. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving monoclonal antibody therapy with chemotherapy may kill more tumor cells. Genetic testing may help doctors determine how the body breaks down and removes irinotecan hydrochloride. Using genetic testing to determine the dose of irinotecan hydrochloride may be more effective and safer than standard dosing.
    Location: 9 locations

  • Combination Chemotherapy with or without Ramucirumab in Treating Patients with Metastatic or Recurrent Pancreatic Cancer

    This randomized phase II trial studies how well combination chemotherapy with or without ramucirumab works in treating patients with pancreatic cancer that has spread from the primary site to other places in the body or come back after a period of time during which the cancer could not be detected. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ramucirumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known if combination chemotherapy is more effective with or without ramucirumab in treating patients with pancreatic cancer.
    Location: 8 locations

  • 131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinistat

    This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.
    Location: 8 locations

  • A Phase 1a / b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10

    This is an open-label Phase 1a / b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.
    Location: 6 locations

  • Combination Chemotherapy with or without Stereotactic Body Radiation Therapy in Treating Patients with Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

    This randomized phase III trial studies combination chemotherapy and stereotactic body radiation therapy to see how well they work compared to combination chemotherapy alone in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes and cannot be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, leucovorin calcium, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. It is not yet known whether combination chemotherapy is more effective with or without stereotactic body radiation therapy in treating patients with pancreatic cancer.
    Location: 7 locations

  • Irinotecan Hydrochloride, Temozolomide, and Combination Chemotherapy in Treating Patients with Newly Diagnosed Ewing Sarcoma

    This phase II trial studies how well irinotecan hydrochloride, temozolomide, and combination chemotherapy work in treating patients with newly diagnosed Ewing sarcoma. Drugs used in chemotherapy, such as irinotecan hydrochloride, temozolomide, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, or by stopping them from dividing.
    Location: 6 locations

  • Combination Chemotherapy with or without Panitumumab in Treating Patients with Colorectal Cancer with Liver Metastases Previously Treated with Surgery

    This randomized phase II trial studies how well combination chemotherapy together with or without panitumumab works in treating patients with colorectal cancer that has spread to the liver previously treated with surgery. Drugs used in chemotherapy, such as floxuridine, irinotecan hydrochloride, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hepatic arterial infusion (HAI) uses a catheter to carry cancer-killing substances directly into the liver. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving floxuridine via HAI and combination chemotherapy with or without panitumumab works better in treating colorectal cancer.
    Location: 6 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)

    In this study, participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that has progressed after first-line standard therapy will be randomized to receive either single agent pembrolizumab or the Investigator's choice of standard therapy with paclitaxel, docetaxel, or irinotecan. The primary study hypothesis is that treatment with pembrolizumab will prolong overall survival (OS) as compared to treatment with standard therapy.
    Location: 6 locations

  • Selinexor with Multiple Standard Chemotherapy Regimens in Treating Patients with Advanced Malignancies

    This phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy regimens in treating patients with malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Studying selinexor with different standard chemotherapy regimens may help doctors learn the side effects and best dose of selinexor that can be given with different types of treatments in one study.
    Location: 5 locations

  • Olaparib and Temozolomide with or without Irinotecan Hydrochloride in Treating Patients with Recurrent or Metastatic Ewing Sarcoma Previously Treated with Chemotherapy

    This phase I trial studies the side effects and best dose of olaparib and temozolomide in treating patients with Ewing sarcoma that has returned or spread to other places in the body after previous treatment with chemotherapy. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving olaparib and temozolomide with irinotecan may be a better treatment for Ewing sarcoma.
    Location: 5 locations

  • A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

    This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.
    Location: 5 locations

  • Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients with Locally Advanced Gastroesophageal or Stomach Cancer

    This pilot phase I trial studies genetic analysis-guided irinotecan hydrochloride dosing of modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin (mFOLFIRINOX) with or without trastuzumab in treating patients with gastroesophageal or stomach cancer that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin calcium may also help fluorouracil work better. Trastuzumab binds to human epidermal growth factor 2 (HER2) on the surface of HER2-positive cancer cells, and may kill tumor cells. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.
    Location: 4 locations

  • Guadecitabine and Irinotecan Hydrochloride or Regorafenib or TAS-102 Alone in Treating Patients with Previously Treated Metastatic Colorectal Cancer

    This partially randomized phase I / II trial studies the side effects and best dose of guadecitabine and to see how well it works when given together with irinotecan hydrochloride or regorafenib or trifluridine / tipiracil hydrochloride combination agent TAS-102 (Tas-102) alone in treating patients with previously treated colorectal cancer that has spread to other parts of the body. Guadecitabine, irinotecan hydrochloride, regorafenib, and TAS-102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Safety and Tolerability Study in Solid Tumors

    This is an open-label, multicenter, sequential dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy. The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part. Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only. Part A will consist of between 12 to 48 participants. Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy. Part B will consist of between 115 to 295 participants. Please note the study is currently only recruiting in the breast cancer cohorts.
    Location: 4 locations


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