Clinical Trials Using Liposomal Irinotecan

Clinical trials are research studies that involve people. The clinical trials on this list are studying Liposomal Irinotecan. 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 1-19 of 19
  • Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients with Pancreatic Cancer That Has Spread

    This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, 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. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.
    Location: 482 locations

  • A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil / Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment

    The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil / leucovorin (5FU / LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
    Location: 15 locations

  • Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC

    This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.
    Location: 7 locations

  • Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

    A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based First-Line Therapy The study will be conducted in two parts: 1. Dose determination of irinotecan liposome injection 2. A randomized, efficacy study of irinotecan liposome injection versus topotecan
    Location: 6 locations

  • Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients with Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin

    This phase II trial studies how well liposomal irinotecan, leucovorin, and fluorouracil work in treating patients with high grade neuroendocrine cancer of gastrointestinal, unknown, or pancreatic origin that does not respond to treatment (refractory) and has spread to other places in the body (advanced). Liposomal irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, 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 liposomal irinotecan, leucovorin and fluorouracil may work better than liposomal irinotecan alone in treating patients with neuroendocrine cancer.
    Location: 3 locations

  • TAS102 and Liposomal Irinotecan in Treating Patients with Gastrointestinal Cancers That Are Locally Advanced, Metastatic, or Cannot Be Removed by Surgery

    This phase I / II trial studies the best dose and how well trifluridine / tipiracil hydrochloride combination agent TAS-102 (TAS-102) and liposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to nearby tissue and lymph nodes (locally advanced), to other places in the body (metastatic), or cannot be removed by surgery. Drugs used in the chemotherapy, such as trifluridine / tipiracil hydrochloride combination agent TAS-102 and liposomal irinotecan, 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.
    Location: 3 locations

  • Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients with Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer

    This phase I / II trial studies the side effects and best dose of liposomal irinotecan and rucaparib when given together with fluorouracil and leucovorin calcium and to see how well they work in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as liposomal irinotecan, 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. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as rucaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Giving liposomal irinotecan and rucaparib together with fluorouracil and leucovorin calcium may work better in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer.
    Location: 3 locations

  • Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan for the Treatment of Previously Treated Advanced Biliary Tract Cancer, NAPOLI-2 Study

    This phase II trial studies how well fluorouracil, leucovorin, and nanoliposomal irinotecan work in treating patients with previously treated biliary tract cancer that has spread to other places in the body (advanced). Fluorouracil is a chemotherapy drug that works by blocking the ability of tumor cells to grow and divide. Leucovorin is a vitamin that allows fluorouracil to work more effectively by increasing the time the active product of fluorouracil is in contact with its target. Nanoliposomal irinotecan is a new formulation of irinotecan, a chemotherapy drug that kills rapidly dividing cells and blocks the ability of tumor cells to grow and divide. Giving fluorouracil, leucovorin, and nanoliposomal irinotecan may work better in treating patients with biliary tract cancer compared to fluorouracil and leucovorin.
    Location: 3 locations

  • Phase 1 Study of MM-398 Plus Cyclophosphamide in Pediatric Solid Tumors

    This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The goal is to find the highest dose of MM-398 that can be given safely when it is used together with the chemotherapy drug Cyclophosphamide.
    Location: 3 locations

  • Fluorouracil, Oxaliplatin, Liposomal Irinotecan with or without Trastuzumab for the First Line Treatment of Advanced Esophageal or Gastric Adenocarcinoma

    This phase II trial studies how well fluorouracil, oxaliplatin, and liposomal irinotecan work alone or with trastuzumab in treating patients with esophageal or gastric adenocarcinoma that has spread to other places in the body (advanced). Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and liposomal irinotecan, 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. Immunotherapy with monoclonal antibodies, such as trastuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving fluorouracil, oxaliplatin, liposomal irinotecan, and trastuzumab may work as a first line treatment for esophageal or gastric adenocarcinoma.
    Location: University of Wisconsin Hospital and Clinics, Madison, Wisconsin

  • Phase I Trial HIPEC With Nal-irinotecan

    The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.
    Location: University of Kentucky / Markey Cancer Center, Lexington, Kentucky

  • Liposomal Irinotecan, 5-FU, Leucovorin, and Paricalcitol in Treating Patients with Advanced Unresectable Pancreatic Cancer That Has Progressed on Gemcitabine-Based Therapy

    This phase I trial studies the best dose and side effects of paricalcitol when given together with liposomal irinotecan, 5-FU, and leucovorin in treating patients with pancreatic cancer whose disease has progressed on therapy containing gemcitabine, and that has spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Paricalcitol is currently used to prevent and treat hyperparathyroidism associated with chronic kidney disease. It may promote tumor cell death by acting on some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal irinotecan, 5-FU and leucovorin, 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. This study may help researchers determine what the recommended dose of paricalcitol is when given with liposomal irinotecan, 5-FU, and leucovorin.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:

    This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC).
    Location: Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

  • Nivolumab, Nal-Irinotecan, Fluorouracil, and Leucovorin as Second Line Therapy in Treating Patients with Advanced Biliary Tract Cancer

    This phase Ib / II trial studies the side effects of nivolumab, nal-irinotecan, fluorouracil, and leucovorin and to see how well they work in treating patients with biliary tract cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as nal-irinotecan, 5-fluorouracil, and leucovorin 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 nivolumab together with chemotherapy (nal-irinotecan, 5-fluorouracil, and leucovorin) may work better in treating patients with biliary tract cancer compared to chemotherapy alone.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • Liposomal Irinotecan in Treating Children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma

    This phase I trial studies the side effects and best dose of liposomal irinotecan in treating children with newly diagnosed diffuse intrinsic pontine glioma. Liposomal irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Liposomal Irinotecan via Convection-Enhanced Delivery and Magnetic Resonance Imaging with Gadolinium in Treating Patients with Recurrent High Grade Glioma

    This phase I trial studies the side effects and best dose of liposomal irinotecan via convection-enhanced delivery when given together with magnetic resonance imaging with gadolinium in treating patients with high grade glioma that has come back. Liposomal irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may reduce the toxicity of irinotecan to healthy tissues while maintaining or increasing its anti-tumor potency. Convection-enhanced delivery is a method of delivering a drug directly into the brain in order to improve the distribution of the drug throughout the brain. Diagnostic procedures, such as magnetic resonance imaging with contrast agent gadolinium, may help doctors to directly monitor the distribution of liposomal irinotecan within the brain. Giving liposomal irinotecan via convection-enhanced delivery while undergoing magnetic resonance imaging with gadolinium may work better in treating patients with high grade glioma.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • MM-398 and Ramucirumab in Treating Patients with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

    This phase I / II trial studies the side effects and best dose of MM-398 and ramucirumab in treating patients with gastric cancer or gastroesophageal junction adenocarcinoma. MM-398 contains a chemotherapy drug called irinotecan, which in its active form interrupts cell reproduction. MM-398 builds irinotecan into a container called a liposome which may be able to release the medicine slowly over time to reduce side effects and increase its ability to kill tumor cells. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving MM-398 and ramucirumab together may work better in treating patients with gastric cancer or gastroesophageal junction adenocarcinoma.
    Location: USC / Norris Comprehensive Cancer Center, Los Angeles, California

  • Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, with a Specific Focus on Patients with Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer

    This phase I trial investigates the side effects and best dose of BAY 1895344 when given together with usual chemotherapy (irinotecan liposome or topotecan) in treating patients with solid tumors that have spread to other places in the body (advanced), with a specific focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan liposome and topotecan, 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. Adding BAY 1895344 to irinotecan liposome or topotecan may help to slow the growth of tumors for longer than seen with those drugs alone.
    Location: Location information is not yet available.

  • Liposomal Irinotecan and Veliparib in Treating Patients with Solid Tumors

    This phase I trial studies the side effects and best dose of veliparib when given together with liposomal irinotecan in treating patients with solid tumors. Liposomal irinotecan and veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 4 locations