Clinical Trials Using Irinotecan Hydrochloride

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 45
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  • Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients with Locally Advanced or Metastatic HER2 / Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

    This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2 / neu amplified colorectal cancer that has spread from where it started to other places in the body (advanced / metastatic) and cannot be removed by surgery. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. Immunotherapy with monoclonal antibodies, such as pertuzumab and cetuximab, 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 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. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.
    Location: 725 locations

  • Vitamin D3 with Chemotherapy and Bevacizumab in Treating Patients with Advanced or Metastatic Colorectal Cancer, SOLARIS Trial

    This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Vitamin D3 may also modulate the immune system and is being studied in the prevention and treatment of some types of cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, 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. Bevacizumab is a monoclonal antibody that binds to Vascular Endothelial Growth Factor (VEGF). VEGF is a substance made by cells that helps the formation of new blood vessels. Bevacizumab may prevent the growth of new blood vessels that tumors need to grow. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients time without disease compared to the usual approach (chemotherapy and bevacizumab).
    Location: 672 locations

  • Combination Chemotherapy with or without Temsirolimus in Treating Patients with Intermediate Risk Rhabdomyosarcoma

    This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy 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. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy or combination chemotherapy plus temsirolimus is more effective in treating patients with intermediate-risk rhabdomyosarcoma.
    Location: 325 locations

  • Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers

    This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, 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. Giving Ramucirumab plus paclitaxel or FOLFIRI, may be helpful in treating advanced or refractory small bowel cancers and may help patients live longer.
    Location: 288 locations

  • Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients with Recurrent or Refractory Solid Tumors

    This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come back after a period of time during which the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide 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. Giving nanoparticle albumin-bound rapamycin, temozolomide, and irinotecan hydrochloride may work better in treating pediatric patients with solid tumors.
    Location: 21 locations

  • Pevonedistat, Irinotecan Hydrochloride, and Temozolomide in Treating Patients with Recurrent or Refractory Solid Tumors or Lymphoma

    This phase I trial studies the side effects and best dose of pevonedistat when given together with irinotecan hydrochloride and temozolomide in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma that have come back after a period of improvement (recurrent) or that do not respond to treatment (refractory). Pevonedistat and irinotecan hydrochloride may stop the growth of cancer 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 cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pevonedistat, irinotecan hydrochloride, and temozolomide may work better in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma compared to irinotecan hydrochloride and temozolomide alone.
    Location: 20 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: 17 locations

  • Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent / Refractory Solid Tumors

    This study will evaluate palbociclib in combination with chemotherapy (temozolomide and irinotecan) in children, adolescents and young adults with recurrent or refractory solid tumors. The main purpose of this study is to evaluate the safety of palbociclib in combination with chemotherapy in order to estimate the maximum tolerated dose. Pharmacokinetics and efficacy of palbociclib in combination with chemotherapy will be evaluated.
    Location: 18 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 alone or in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.
    Location: 20 locations

  • Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients with Relapsed or Refractory Solid Tumors

    This phase I / II trial studies the side effects and best dose of adavosertib and irinotecan hydrochloride in treating younger patients with solid tumors that have come back (relapsed) or that have not responded to standard therapy (refractory). Adavosertib and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 21 locations

  • 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 VX-970 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). VX-970 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 13 locations

  • Losartan and Nivolumab in Combination with Combination Chemotherapy and SBRT in Treating Patients with Localized Pancreatic Cancer

    This phase II trial studies how well losartan and nivolumab work in combination with combination chemotherapy and stereotactic body radiation therapy (SBRT) in treating patients with pancreatic cancer that has not spread to other parts of the body. Losartan is a drug that is used to lower blood pressure. Immunotherapy with monoclonal antibodies, such as nivolumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, irinotecan hydrochloride, 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. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. It is not yet known how well losartan and nivolumab work in combination with combination chemotherapy and stereotactic body radiation therapy in treating patients with localized pancreatic cancer.
    Location: 9 locations

  • A Vaccine (Personalized Cancer Vaccine RO7198457), Atezolizumab, and Combination Chemotherapy for the Treatment of Resectable Stage I-III Pancreatic Cancer

    This phase I trial studies how well a personalized cancer vaccine RO7198457 works in combination with atezolizumab and fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin in treating patients with stage I-III pancreatic cancer that has been removed by surgery (resected). The personalized cancer vaccine RO7198457 is a vaccine that is customized according to changes (mutations) in a patient's tumor cells so that it can be recognized by the immune system and target the tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab, 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 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. Giving personalized cancer vaccine RO7198457, atezolizumab, fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin may work better compared to chemotherapy alone 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: 7 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

  • ESP1 / SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and / or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma

    The purpose of this study is to define the dose-limiting toxicities and maximum tolerated dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of temozolomide and / or irinotecan in patients with pre-treated incurable Ewing sarcoma.
    Location: 5 locations

  • Ramucirumab and Irinotecan Hydrochloride in Treating Patients with Metastatic or Locally Advanced Gastric or Gastroesophageal Junction Cancer

    This phase II trial studies how well ramucirumab and irinotecan hydrochloride work in treating patients with gastric or gastroesophageal junction cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other parts of the body (metastatic). 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. Irinotecan hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ramucirumab and irinotecan hydrochloride may be a better treatment for patients with metastatic or advanced gastric or gastroesophageal junction cancer.
    Location: 4 locations

  • Olaparib and Temozolomide with or without Irinotecan Hydrochloride in Treating Patients with Recurrent or Metastatic Ewing Sarcoma or Rhabdomyosarcoma 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 or rhabdomyosarcoma that has returned (recurrent) or spread to other places in the body (metastatic) or 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 or rhabdomyosarcoma.
    Location: 4 locations

  • Early Identification and Treatment of Occult Metastatic Disease in Stage III Colorectal Cancer

    This phase III trial studies how well either FOLFIRI (leucovorin, fluorouracil, and irinotecan), active surveillance, nivolumab, or encorafenib, binimetinib, and cetuximab work in decreasing recurrence (chance of the cancer coming back) in patients with stage III colorectal cancer who are ctDNA positive. If all the cancer is not killed after initial treatment, bloods tests may be able to detect tumor DNA in the blood called circulating tumor DNA (ctDNA). This is genetic material unique to the cancer that may be present in the blood stream and can be identified through a ctDNA blood test. Cancer researchers believe that ctDNA in the blood stream may be an indicator that cancer is more likely to recur. Chemotherapy drugs, such as leucovorin, fluorouracil, and 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. Nivolumab is an anti-PD-1 antibody. It works by attaching to and blocking a molecule called PD-1. PD-1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus potentially allowing immune cells to recognize and destroy cancer cells. Encorafenib in combination with binimetinib and cetuximab may target the BRAF V600E-mutation in colorectal cancer. When this mutation is present, it switches on pathway called the MAPK pathway which stimulates cell division and leads to uncontrolled cell growth. Encorafenib, binimetinib and cetuximab target different parts of this important signaling pathway in tumor cells with this mutation and may slow down their growth and communication. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. This study is being done to determine whether there are differences in cancer recurrence in ctDNA positive patients treated with additional therapy versus put on active surveillance.
    Location: 3 locations

  • TAS-102 and Irinotecan in 2L+ gastric and gastroesophageal adenocarcinomas

    This trial studies how well TAS102 and irinotecan works for the treatment of gastric or gastroesophageal adenocarcinoma that has spread to other places in the body (advanced), has come back (recurrent), or cannot be removed by surgery (unresectable) after one line of prior standard chemotherapy with a fluoropyrimidine and platinum chemotherapy combination. Drugs used in chemotherapy, such as TAS-102, 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 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving TAS102 and irinotecan may delay tumor growth.
    Location: 2 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: 3 locations

  • Study of MK-4280 as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy AND MK-4280A as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001)

    This is a safety and pharmacokinetics study of MK-4280 as monotherapy and in combination with pembrolizumab (MK-3475) AND MK-4280A as monotherapy in adults with metastatic solid tumors for which there is no available therapy which may convey clinical benefit. Part A of this study is a dose escalation design in which participants receive MK-4280 as monotherapy or MK-4280 in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RPTD), as determined by dose-limiting toxicity, for MK-4280 in combination with pembrolizumab in participants with advanced solid tumors. Part B will also assess the efficacy of MK-4280 as monotherapy and in combination with pembrolizumab with and without chemotherapy AND MK-4280A as monotherapy in expansion cohorts.
    Location: 5 locations

  • Pharmacokinetic Study of PM01183 in Combination With Irinotecan in Patients With Selected Solid Tumors

    Prospective, open-label, dose-ranging, uncontrolled phase I study with PM01183 in combination with irinotecan to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with irinotecan in patients with selected advanced solid tumors.
    Location: 2 locations

  • Risk Adapted Focal Proton Beam Radiation and / or Surgery in Patients with Low, Intermediate, and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

    This phase II trial studies how well chemotherapy, surgery, and radiation therapy work in treating patients with newly diagnosed rhabdomyosarcoma that has spread to other parts of the body. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, and cyclophosphamide, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.
    Location: 2 locations

  • Prexasertib and Irinotecan for the Treatment of Relapsed or Refractory Desmoplastic Small Round Cell Tumor or Rhabdomyosarcoma

    This phase I / II trial studies the best dose, the side effects, and how well prexasertib and irinotecan work in treating patients with desmoplastic small cell tumor or rhabdomysosarcoma that has come back (relapsed) or does not respond to treatment (refractory). Prexasertib is a type of medication called a checkpoint kinase inhibitor. It works by stopping cancer cells from repairing damage to themselves and their deoxyribonucleic acid (DNA) (genes), which may lead to death of cancer cells. Drugs used in chemotherapy, such as 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. The purpose of this study is to test whether prexasertib is a safe and effective treatment for patients with desmoplastic small round cell tumor or rhabdomyosarcoma when given with irinotecan.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York


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