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 126

  • Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas

    This study will be a prospective, open-label, single arm, multi-center phase 2 clinical trial of mFOLFOX6 + trastuzumab + avelumab in first-line, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary objective of this study is to estimate the best objective response rate (CR or PR, ORR) in these patients within 24 weeks by RECIST 1.1 criteria. Secondary objectives include; estimating PFS by both RECIST 1.1 and iRECIST criteria, estimating OS, estimating the disease control rate (DCR) at 24 weeks by RECIST 1.1 and iRECIST, and characterizing the safety issues associated with this regimen.
    Location: 3 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. Drugs used in chemotherapy, 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

  • Chemotherapy with or without Radiation Therapy in Treating Participants with Gastric Cancer after Surgical Analysis of Lymph Nodes

    This early phase I pilot trial studies how well chemotherapy with or without radiation therapy work in treating participants with gastric cancer who have undergone surgical analysis of the lymph nodes. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, capecitabine, 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. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. It is not yet known whether giving chemotherapy and radiation will work better in treating participants with gastric 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

  • 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

  • Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers

    This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (FOLFOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).
    Location: 5 locations

  • Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975 / KEYNOTE-975)

    The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Overall Survival (OS) and Event-free survival (EFS) in: - participants with esophageal squamous cell carcinoma (ESCC), - participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, and - all participants. The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: - OS in participants with ESCC, - OS in participants whose tumors express PD-L1 CPS ≥10, - OS in all participants, - EFS in participants with ESCC, - EFS in participants whose tumors express PD-L1 CPS ≥10, and - EFS in all participants.
    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

  • Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers

    This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary efficacy of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma.
    Location: 5 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

  • Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859 / KEYNOTE-859)

    The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), and progression-free survival (PFS).
    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

  • A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants With Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

    The purpose of this study is to determine the Objective Response Rate (ORR) of zolbetuzimab as a single agent as assessed by an independent central reader. This study will also assess the ORR and Progression Free Survival (PFS) of zolbetuximab in combination with mFOLFOX6 and in combination with pembrolizumab, assess the safety and tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and immunomodulatory effects of zolbetuximab as a single agent and in combination with mFOLFOX6 and in combination with pembrolizumab. This study will also evaluate the pharmacokinetics (PK) of zolbetuximab, oxaliplatin, fluorouracil (5-FU), and pembrolizumab, evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 and in combination with pembrolizumab based on both investigator and independent central reader assessment, assess Overall Survival (OS) of zolbetuximab as a single agent and in combination with pembrolizumab.
    Location: 4 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.
    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

  • Pembrolizumab, Combination Chemotherapy, and Radiation Therapy before Surgery in Treating Adult Patients with Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery

    This phase Ib / II trial studies the side effects and best way to give pembrolizumab with combination chemotherapy and radiation therapy before surgery and to see how well it works in treating adult patients with gastroesophageal junction or gastric cardia cancer that has spread from where it started to nearby tissue (locally advanced) and can be removed by surgery. 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 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 pembrolizumab, combination chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: 2 locations

  • Study of MK-4280 as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib 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 (RP2D), as determined by dose-limiting toxicity, for MK-4280 in combination with pembrolizumab or pembrolizumab and lenvatinib in participants with advanced solid tumors. Part B will also assess the efficacy of MK-4280 as monotherapy; MK-4280 in combination with pembrolizumab with and without chemotherapy; MK-4280 in combination with pembrolizumab and lenvatinib; and MK-4280A as monotherapy in expansion cohorts.
    Location: 5 locations

  • Intraperitoneal Docetaxel in Combination with mFOLFOX6 for the Treatment of Gastric Cancer Patients with Peritoneal Carcinomatosis

    This phase I trial evaluates the side effects and best dose of intraperitoneal docetaxel when given together with intravenous combination chemotherapy (mFOLFOX6) in treating patients with gastric cancer that has spread to the peritoneal (abdominal) surface (peritoneal carcinomatosis). Docetaxel works by inhibiting DNA, RNA, and protein creation thus preventing the growth of tumor cells. mFOLFOX6 is a combination of oxaliplatin, leucovorin, and fluorouracil that work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) kills more tumor cells. Giving docetaxel directly into the abdomen (intraperitoneal) may result in more of the drug reaching the tumor cells. Giving intraperitoneal docetaxel and intravenous mFOLFOX6 chemotherapy may be effective in treating gastric cancer patients with peritoneal carcinomatosis.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma

    This phase Ib trial investigates the side effects and how well a shorter course of chemotherapy and radiation treatment (chemoradiotherapy) for 2 weeks instead of 5 weeks followed by standard chemotherapy works in treating patients with gastric cancer who are scheduled to have treatment and then surgery to remove the tumor. Chemotherapy drugs, such as capecitabine 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. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving short-course chemo-radiotherapy before chemotherapy and surgery may help to control the disease.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Pembrolizumab and Chemoradiotherapy for the Treatment of Unresectable Gastroesophageal Cancer

    This phase I trial investigates how well pembrolizumab and chemoradiotherapy works in treating patients with gastroesophageal cancer that cannot be removed by surgery (unresectable). 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. Chemotherapy drugs, such as fluorouracil, oxaliplatin and docetaxel 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 photons to kill tumor cells and shrink tumors. Giving pembrolizumab together with chemoradiotherapy may help to control gastroesophageal cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Efficacy and Safety of Olaparib, Olaparib + Bevacizumab Compared to Bevacizumab + 5-Fluorouracil (FU)

    This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with Fluorouracil (5-FU) in participants with unresectable or metastatic colorectal cancer (CRC) who have not progressed following first-line induction of FOLFOX with bevacizumab. Hypothesis 1 - Olaparib + Bevacizumab is superior to 5-FU + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) in the treatment of CRC. Hypothesis 2 - Olaparib is superior to 5-FU + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR) in the treatment of CRC.
    Location: 2 locations

  • Short-Course Radiation Therapy and Combination Chemotherapy for the Treatment of Rectal Cancer, SHORT-FOX Study

    This phase II trial studies the effect of short-course radiation therapy and combination chemotherapy in treating patients with rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI), 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 short-course radiation therapy and FOLFOXIRI may increase the chance of the tumor completely going away, and ultimately lead to omission of surgery in patients with rectal cancer.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Pembrolizumab with Chemotherapy and Radiation Therapy before Surgery for the Treatment of Stage II-IV Rectal Cancer

    This phase I trial investigates the side effects of pembrolizumab in combination with chemotherapy and radiation therapy before surgery, and to see how well they work in treating patients with stage II-IV rectal cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as capecitabine 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. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving pembrolizumab with chemotherapy and radiation therapy before surgery may make the tumor smaller and may prevent cancer from returning.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio