Clinical Trials Using Gemcitabine Hydrochloride

Clinical trials are research studies that involve people. The clinical trials on this list are studying Gemcitabine 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 104
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  • Targeted Treatment (Ramucirumab Plus Pembrolizumab) for Advanced Non-Small Cell Lung Cancer (A Lung-MAP Non-Matched Treatment Trial)

    This phase II Lung-MAP Non-Matched treatment trial studies how well ramucirumab and pembrolizumab work versus standard of care in treating patients with non-small cell lung cancer that is stage IV or has come back (recurrent). 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 standard of care chemotherapy for non-small cell lung cancer, such as docetaxel, gemcitabine hydrochloride, and pemetrexed, 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 and pembrolizumab together may work better in treating patients with non-small lung cancer compared to standard of care.
    Location: 743 locations

  • Gemcitabine Hydrochloride and Cisplatin with or without Nab-Paclitaxel in Treating Patients with Newly Diagnosed Advanced Biliary Tract Cancers

    This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, 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. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
    Location: 599 locations

  • Gemcitabine Hydrochloride and Cisplatin in Treating Patients with Invasive Bladder Urothelial Cancer

    This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating patients with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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: 298 locations

  • Individualized Treatment in Treating Patients with Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

    There are two study questions we are asking in this randomized phase II / III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel 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. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
    Location: 147 locations

  • Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients with Locally Advanced Squamous Cell Cancer of the Vulva

    This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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 radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
    Location: 166 locations

  • Cisplatin and Gemcitabine Hydrochloride with or without ATR Kinase Inhibitor M6620 in Treating Patients with Metastatic Urothelial Cancer

    This randomized phase II trial studies how well cisplatin and gemcitabine hydrochloride with or without ATR kinase inhibitor M6620 works in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as cisplatin and gemcitabine 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. ATR kinase inhibitor M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin and gemcitabine hydrochloride work better alone or with ATR kinase inhibitor M6620 in treating patients with urothelial cancer.
    Location: 31 locations

  • Clinical and Molecular Risk-Directed Craniospinal Irradiation and Combination Chemotherapy in Treating Younger Patients with Newly Diagnosed Medulloblastoma

    This partially randomized phase II trial studies clinical and molecular risk-directed craniospinal irradiation and combination chemotherapy in treating younger patients with newly diagnosed medulloblastoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, carboplatin, cyclophosphamide, vincristine sulfate, vismodegib, gemcitabine hydrochloride, and pemetrexed disodium, 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 clinical and molecular risk-directed radiation therapy and combination chemotherapy may kill more tumor cells.
    Location: 13 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: 19 locations

  • Nab-Paclitaxel and Gemcitabine Hydrochloride in Treating Teenagers or Young Adults with Recurrent or Refractory Osteosarcoma, Ewing Sarcoma, Rhabdomyosarcoma, or Soft Tissue Sarcoma

    This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride work in treating teenagers or young adults with osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or soft tissue sarcoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as nab-paclitaxel and gemcitabine 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.
    Location: 17 locations

  • A Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

    This Phase 1 / 2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. The study is divided into two parts: single agent FT-2102 followed by combination therapy. Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored. Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102+nivolumab (hepatobiliary tumors) and FT-2102+gemcitabine / cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.
    Location: 13 locations

  • A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

    A Phase Ib / II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.
    Location: 12 locations

  • Atezolizumab, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients with Metastatic and Muscle Invasive Bladder Cancer

    This pilot phase II trial studies the side effects of atezolizumab when given together with gemcitabine hydrochloride and cisplatin and how well it works in treating patients with bladder cancer that has spread to other parts of the body and the muscle. 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 gemcitabine hydrochloride and cisplatin, 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 atezolizumab, gemcitabine hydrochloride, and cisplatin may work better in treating bladder cancer.
    Location: 10 locations

  • Gemcitabine Hydrochloride, Nab-Paclitaxel, PEGPH20, and Rivaroxaban in Treating Patients with Stage III-IV Pancreatic Cancer That Cannot Be Removed by Surgery

    This pilot phase II trial studies the side effects and how well gemcitabine hydrochloride, nab-paclitaxel, pegylated recombinant human hyaluronidase PH20 (PEGPH20), and rivaroxaban work in treating patients with stage III-IV pancreatic cancer that has spread to other places in the body (metastatic) and cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and nab-paclitaxel, 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. PEGPH20 may stop the growth of tumor cells by breaking down hyaluronan, a tissue component needed for cell growth. However, PEGPH20 is also associated with an increased risk for blood clots. Rivaroxaban is a blood thinner that may help prevent blood clots. Giving gemcitabine hydrochloride, nab-paclitaxel, PEGPH20, and rivaroxaban together may work better in treating pancreatic cancer.
    Location: 10 locations

  • Gemcitabine Hydrochloride and Cisplatin in Treating Patients with High-Grade Urothelial Cancer

    This phase II trial studies how well giving gemcitabine hydrochloride together with cisplatin before surgery work in treating patients with high-grade urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin (GC), 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 combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: 10 locations

  • A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

    The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints. The first primary completion date of Pathological Complete Response is anticipated to be reached April 2020. The completion date for all primary outcome measures is expected May 2023.
    Location: 12 locations

  • Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant / Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671 / KEYNOTE-671)

    This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent central review (BICR); and 2) overall survival (OS).
    Location: 9 locations

  • Atezolizumab, Gemcitabine Hydrochloride, and Cisplatin as First-Line Therapy in Treating Patients with Locally Advanced or Metastatic Urothelial Cancer

    This randomized phase II trial studies how well atezolizumab works when given together with gemcitabine hydrochloride and cisplatin as first-line therapy in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes, or other places in the body. 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 gemcitabine hydrochloride and cisplatin, 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 atezolizumab with chemotherapy may kill more tumor cells.
    Location: 8 locations

  • Second-Line Pembrolizumab in Combination with Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients with Relapsed or Refractory Hodgkin Lymphoma

    This phase II trial studies the side effects and how well pembrolizumab in combination with gemcitabine, vinorelbine, and pegylated liposomal doxorubicin hydrochloride work in treating patients with Hodgkin lymphoma that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 gemcitabine, vinorelbine, and pegylated liposomal doxorubicin hydrochloride, 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 pembrolizumab, gemcitabine, vinorelbine, and pegylated liposomal doxorubicin hydrochloride may work better at treating Hodgkin lymphoma.
    Location: 8 locations

  • A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients

    This study is a multi-center, randomized, open label, Phase III clinical trial for advanced Nasopharyngeal Carcinoma(NPC) Patients. Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's cytotoxic T cells (CTL) that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T cells may kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3 T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 30 hospital centers across Asia and the United States. This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38 patients at the National Cancer Centre, Singapore. This trial produced the best published 2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with advanced NPC who received autologous EBV-specific CTL. Kindly see https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC3978790 / for the Phase 2 publication titled "Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and / or Locally Recurrent Nasopharyngeal Carcinoma".
    Location: 7 locations

  • Stereotactic Body Radiation Therapy and Chemotherapy in Treating Patients with Stage IIA-IIIA Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

    This phase I trial studies the side effects and best dose of stereotactic body radiation therapy when given together with chemotherapy in treating patients with stage IIA-IIIA non-small cell lung cancer that cannot be removed by surgery. 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. Drugs used in chemotherapy, such as pemetrexed disodium, cisplatin, carboplatin, and gemcitabine 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 stereotactic body radiation therapy with chemotherapy may kill more tumor cells.
    Location: 7 locations

  • Gemcitabine Hydrochloride and Nivolumab with Carboplatin or Oxaliplatin in Treating Patients with Locally Advanced or Metastatic Urothelial Cancer

    This phase II trial studies how well gemcitabine hydrochloride and nivolumab with carboplatin or oxaliplatin work in treating patients with urothelial cancer that has spread from its original site of growth to nearby tissues or lymph nodes or that has spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, carboplatin, 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. 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. It is not yet known whether gemcitabine hydrochloride and nivolumab with carboplatin or oxaliplatin may work better in treating patients with urothelial cancer.
    Location: 6 locations

  • ASCENT-Study of Sacituzumab Govitecan in Refractory / Relapsed Triple-Negative Breast Cancer

    This is an international, multi-center, open-label, randomized, Phase III study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC) Patients will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor progression leading to treatment withdrawal will be assessed by the investigator. Starting with the initial dose of sacituzumab govitecan or TPC, Imaging assessments will be obtained at least every 8 weeks until the occurrence of progression of disease requiring discontinuation of further treatment. All patients, will be followed every 4 weeks during the first year and every 8 weeks thereafter for survival follow-up.
    Location: 7 locations

  • Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel before Surgery in Treating Participants with High-Risk Bile Duct Cancer in the Liver

    This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel work before surgery in treating participants with high-risk bile duct cancer in the liver (intrahepatic cholangiocarcinoma). Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine 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 combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: 8 locations

  • A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer (Morpheus-TNBC)

    This is a Phase Ib / II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in patients with metastatic or inoperable locally advanced TNBC who had disease progression during or following first-line metastatic treatment with chemotherapy. The study will be performed in two stages. During Stage 1, participants will be randomized to capecitabine (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new doublet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and / or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
    Location: 6 locations

  • A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer

    The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.
    Location: 11 locations


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