Clinical Trials Using Fluorouracil

Clinical trials are research studies that involve people. The clinical trials on this list are studying Fluorouracil. 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 51-75 of 135

  • A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR) / Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

    The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H / dMMR mCRC participants.
    Location: 5 locations

  • A Study of RGX-202-01 as a Single Agent and as Combination Therapy in Patients With Advanced Gastrointestinal Malignancies

    RGX-202-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-202-01 as a single agent and in combination with FOLFIRI + / - bevacizumab. RGX-202-01 is a small molecule inhibitor of the creatine transporter SLC6a8, a novel metabolic target that drives gastrointestinal cancer progression. During the dose escalation stage, multiple doses of orally administered RGX-202-01 with or without FOLFIRI + / - bevacizumab (single agent or combination therapy) will be evaluated in patients with advanced gastrointestinal tumors (i.e., locally advanced and unresectable, or metastatic) who have had PD on available standard systemic therapies or for which there are no standard systemic therapies of relevant clinical impact. In the expansion stage of the study, additional patients with colorectal cancer (CRC) selected by expression of the creatine kinase B (CKB) biomarker will be treated at the MTD (or maximum tested dose if no MTD is identified, or dose below the MTD if there is evidence suggesting a more favorable risk / benefit profile). This stage will provide further characterization of the safety, efficacy, PK, and pharmacodynamics of RGX-202-01 in combination with FOLFIRI plus bevacizumab.
    Location: 5 locations

  • Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

    This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC / GEJC) (MATTERHORN).
    Location: 4 locations

  • Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic or Unresectable Gastroesophageal Cancers (BMS Protocol CA209-76L)

    This is a randomized phase II study examining nivolumab alone versus radiation therapy with nivolumab in subjects who did not have disease progression to initial therapy with the combination of FOLFOX and Nivolumab.
    Location: 3 locations

  • A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer

    Subjects will be offered the opportunity to participate in a randomized, controlled, 2-arm, unblinded multicenter trial (RCT). There will be 2 study arms: the control arm receiving chemotherapy with the modified FOLFIRINOX regimen alone; and the irreversible electroporation (IRE) arm, receiving chemotherapy with the modified FOLFIRINOX regimen followed by IRE with the NanoKnife System using either an open or a percutaneous approach. All subjects will be treated with the modified FOLFIRINOX regimen for at least 3 months; randomization to either control or IRE arm will take place at the time of completion of the 3 month modified FOLFIRINOX chemotherapy regimen. Randomization will be conducted centrally. Subjects will be randomized in a 1:1 ratio and must be found to have no evidence of disease progression after completion of the 3 month modified FOLFIRINOX chemotherapy regimen in order to participate in the RCT. All radiologic assessments will be performed as consistent with the imaging protocol. All post induction and post IRE treatments are left to the discretion of the treating physician. The minimum period of follow-up will be for 24 months or until death.
    Location: 4 locations

  • A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

    The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, as well as Nivolumab / Ipilimumab for selected advanced solid tumors.
    Location: 3 locations

  • 6-Hour Oxaliplatin in Preventing Nerve Damage in Patients with Advanced or Metastatic Gastrointestinal Cancer

    This phase II trial studies how well giving oxaliplatin over 6 hours works in preventing nerve damage in patients with gastrointestinal cancer that has spread to other places in the body. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Giving oxaliplatin over a longer period of time (6 hours) may prevent or delay the development of nerve damage, which may keep patients on standard doses of chemotherapy longer, without having to delay treatment.
    Location: 4 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

  • Nab-Paclitaxel, Gemcitabine, and Hypofractionated Ablative Proton Therapy in Treating Patients with Locally Advanced Pancreatic Cancer

    This phase I trial studies the side effects and best dose of nab-paclitaxel and gemcitabine when given together with hypofractionated ablative proton beam radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). Chemotherapy drugs, such as nab-paclitaxel and gemcitabine, 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. Giving nab-paclitaxel, gemcitabine, and proton beam radiation therapy may work better in treating patients with pancreatic cancer.
    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

  • A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies

    This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and / or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously-treated solid tumors or hematologic malignancies. Only chemotherapy combination (ABBV-621 + FOLFIRI) enrolling participants with RAS-mutant CRC who have received one prior line of therapy is open for enrollment.
    Location: 3 locations

  • Paediatric Hepatic International Tumour Trial

    The PHITT trial is an over-arching study for patients with Hepatoblastoma (HB) and Hepatocellular Carcinoma (HCC). This trial will use a risk-adapted approach to the treatment of children diagnosed with HB. Children with HCC will be included as a separate cohort.
    Location: 3 locations

  • Modified Chemotherapy Alternated with Biweekly Gemcitabine plus Nab-Paclitaxel for the Treatment of Stage IV Pancreatic Cancer

    This phase II trial studies how well modified combination chemotherapy alternated with biweekly gemcitabine plus nab-paclitaxel works in treating patients with stage IV pancreatic cancer. Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, 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. This trial is being done to examine the effects of two active chemotherapy regiments, modified combination chemotherapy and biweekly gemcitabine plus nab-paclitaxel, administered as a combined, alternating treatments in patients with pancreatic cancer.
    Location: 2 locations

  • Chemotherapy followed by Chemoradiation for the Treatment of Locally Advanced Esophagogastric Cancer

    This phase II trial investigates the effect of chemotherapy followed by chemoradiation in treating patients with esophagogastric cancer that has spread to nearby tissue or lymph nodes. Chemotherapy drugs, such as liposomal irinotecan, oxaliplatin, leucovorin, fluorouracil, paclitaxel, and carboplatin, 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 radiation therapy after chemotherapy may kill remaining tumor cells.
    Location: 3 locations

  • PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients with Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

    This trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Drugs used in chemotherapy, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, 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. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and / or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.
    Location: 2 locations

  • APX005M, mFOLFOX Chemotherapy, and Radiation Therapy for the Treatment of Stage II-III Rectal Cancer, The INNATE Trial

    This phase II trial investigates how well APX005M, modified (m)FOLFOX chemotherapy regimen (fluorouracil, leucovorin calcium, oxaliplatin), and radiation therapy works in treating patients with rectal cancer. APX005M is a type of immunotherapy called a monoclonal antibody which may help treat cancer by strengthening the immune system. Chemotherapy drugs, such as fluorouracil, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of APX005M to mFOLFOX (standard of care chemotherapy for rectal cancer) and radiation therapy may help improve response rates and long-term outcomes in treatment of locally advanced rectal cancer patients.
    Location: 2 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

  • Radiation Therapy and Chemotherapy in Treating Patients with Stage I-IIIB Rectal Cancer

    This phase II trial studies how well patients with stage I-IIIB rectal cancer respond to a short course of radiation therapy followed by chemotherapy. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine 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. A combination of radiation therapy and chemotherapy may prevent patients from needing surgery, could delay their need for surgery, or may mean that they need less drastic surgery and could potentially avoid a permanent ostomy (a surgically created connection between the intestine and the abdominal wall that allows for elimination of stool).
    Location: 2 locations

  • 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: 2 locations

  • Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma

    This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.
    Location: 2 locations

  • Preservation of Organs in Participants with Early Rectal Cancer

    This phase II trial studies preservation of organs in patients with early rectal cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and calcium fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving more than one drug (combination chemotherapy), and giving them after local excision may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
    Location: 2 locations

  • Carbon Ion or Conventional Photon Radiation Therapy and Chemotherapy in Treating Patients with Locally Advanced, Unresectable Pancreatic Cancer

    This phase III trial studies how well carbon ion radiation therapy works compared to conventional photon radiation therapy when giving together with chemotherapy in treating patients with pancreatic cancer that has spread from its original site of growth to nearby tissues or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Carbon ion radiation therapy uses charged carbon particles to kill tumor cells and shrink tumors. Conventional photon radiation therapy, such as intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Drugs used in chemotherapy, such as gemcitabine, nab-paclitaxel, capecitabine, fluorouracil, irinotecan, leucovorin 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. Given carbon ion radiation therapy with chemotherapy may kill more tumor cells in patients with pancreatic cancer compared to conventional photon radiation therapy and chemotherapy.
    Location: UT Southwestern / Simmons Cancer Center-Dallas, Dallas, Texas

  • PEN-866 in Patients With Advanced Solid Malignancies

    Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1 / 2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
    Location: 2 locations

  • Combination Chemotherapy and Radiation Therapy in Treating Patients with Locally Advanced HPV Positive Oropharynx Cancer

    This phase II trial studies how well combination chemotherapy followed by reduced dose chemoradiation therapy works in curing patients with locally advanced human papillomavirus (HPV) positive oropharynx cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil and carboplatin 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 prior to chemoradiation therapy may result in be less early and late toxicity and side effects then standard chemoradiotherapy in HPV positive oropharynx cancer as there will be fewer side effects.
    Location: 2 locations

  • Intravenous Leucovorin, Fluorouracil, Paclitaxel and Intraperitoneal Paclitaxel for the Treatment of Stomach Cancer with Peritoneal Carcinomatosis, STOPGAP Study

    This phase II trial studies the effect of intravenous leucovorin, fluorouracil, paclitaxel and intraperitoneal paclitaxel in treating patients with stomach cancer that has spread in the abdominal lining (peritoneum) called as peritoneal carcinomatosis. Currently, patients with gastric cancer who have cancer spread to the abdominal lining are only treated with intravenous chemotherapy, which is chemotherapy administered through the vein into the body. Chemotherapy drugs, such as leucovorin, fluorouracil, 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. Giving paclitaxel via infusion into the abdominal cavity through a small access device implanted into the abdominal fat tissue (intraperitoneal) together with intravenous chemotherapy may shrink tumor growth and improve survival in patients with stomach cancer and peritoneal carcinomatosis.
    Location: UC Irvine Health / Chao Family Comprehensive Cancer Center, Orange, California