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 26-50 of 135

  • 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 and CAPOX). 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. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).
    Location: 9 locations

  • Dostarlimab before Chemoradiotherapy and Surgery for the Treatment of Locally Advanced Mismatch Repair Deficiency or Microsatellite Instability Rectal Cancer

    This phase II trial studies how well dostarlimab (TSR-042) before standard chemoradiotherapy and surgery works in treating patients with mismatch repair deficiency or microsatellite instability rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Dostarlimab is a type of medication called an antibody, which is a protein made by the immune system to protect the body from harm. Dostarlimab blocks another protein (programmed cell death receptor-1, or PD-1) that usually acts as a “brake” on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target tumor cells and kill them.
    Location: 7 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. Chemotherapy drugs, 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

  • Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a Kras Mutation

    The purpose of the Phase 1b / 2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily, for 5 consecutive days on Day 1-5 of each 14-day course in each 28-day cycle, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.
    Location: 7 locations

  • Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon 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 colon 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: 7 locations

  • Pembrolizumab / Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811 / KEYNOTE-811)

    The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).
    Location: 7 locations

  • Hypofractionated Ablative Intensity-Modulated Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients with Potentially Resectable Locally Advanced Pancreatic Cancer

    This phase II trial studies how well hypofractionated ablative intensity-modulated radiation therapy and capecitabine or fluorouracil work in treating patients with pancreatic cancer that has spread from its original site of growth to nearby tissues or lymph nodes and may be able to be removed by surgery. 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. Drugs used in chemotherapy, 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. Giving hypofractionated ablative intensity-modulated radiation therapy and capecitabine or fluorouracil may work better in treating patients with pancreatic cancer.
    Location: 7 locations

  • Combination Chemotherapy and Nab-Paclitaxel in Treating Patients with Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery

    This phase II trial studies how well combination chemotherapy and nab-paclitaxel work in treating patients with gastric or gastroesophageal junction cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, 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.
    Location: 7 locations

  • Durvalumab, an Anti-PDLI Antibody, Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation before Surgery for Esophageal Cancer

    This phase Ib / II trial studies the side effects of durvalumab when given together with chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal junction cancer. Both durvalumab and tremelimumab are antibodies (proteins) which bind to cells involved in the immune system. Antibodies are normally made by the body to destroy germs, like bacteria and viruses. The antibodies in this study are designed to boost the body’s immune system, by allowing immune cells to be more active and fight the cancer. Durvalumab works by interacting with an immune molecule called PD-L1, located on the tumor cells and white blood cells. Tremelimumab works by interacting with an immune molecule called CTLA-4, located on white blood cells. Both durvalumab and tremelimumab may help strengthen the immune system. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin, carboplatin 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving durvalumab together with chemotherapy and radiation therapy before surgery may work better at treating patients with esophageal or gastroesophageal junction cancer.
    Location: 7 locations

  • BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER)

    To evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC
    Location: 8 locations

  • A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

    This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).
    Location: 7 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: 9 locations

  • A Randomized Phase 2 / 3 Multi-Center Study of SM-88 in Patients With Metastatic Pancreatic Cancer

    A prospective, open-label phase 2 / 3 trial in metastatic pancreatic cancer subjects who have failed two lines of prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. (Part 1 enrollment complete) In the initial stage of the trial (36 subjects), two dose levels of SM-88's metyrosine-derivative was evaluated. (Part 2 actively enrolling) The second part will consist of a subsequent expansion of the trial to further assess safety and efficacy of SM-88 used with MPS containing the selected SM-88 RP2D from Part 1. A total of 250 subjects in the second part will be randomized 1:1 either to the SM-88 arm (125 subjects) or Physician's Choice of therapy for the Control Arm (125 subjects). Subjects should have previously received two lines of prior systemic therapy.
    Location: 7 locations

  • High-Dose-Rate Brachytherapy and Chemotherapy in Treating Patients with Locally Recurrent or Residual Rectal or Anal Cancer Undergoing Non-operative Management

    This phase I trial studies the side effects and best dose of high-dose-rate brachytherapy when given together with chemotherapy in treating patients with rectal or anal cancer that has come back or gotten worse and cannot be treated with surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. High-dose-rate (HDR) brachytherapy uses the radioactive material to deliver a high radiation dose in a short period of time to the tumor. It may also send less radiation to nearby healthy tissues and may reduce the risk of side effects. Drugs used in chemotherapy, 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. Giving HDR brachytherapy together with capecitabine or fluorouracil may kill more tumor cells.
    Location: 6 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: 6 locations

  • Docetaxel and Trastuzumab before Surgery for the Treatment of HER2-Positive Stage II-III Breast Cancer in Nigerian Women, the ARETTA Trial

    This phase II trial studies the effect of docetaxel and trastuzumab before surgery in treating HER2 positive stage II-III breast cancer in Nigerian women. Chemotherapy drugs, such as 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. Trastuzumab is a form of targeted therapy because it attaches 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. This study is being done to determine how effective and safe docetaxel and trastuzumab are before surgery in Nigerian women with breast cancer.
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

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

    This phase Ib / II trial studies the side effects of nivolumab, nal-irinotecan, fluorouracil, and leucovorin and to see how well they work in treating patients with biliary tract cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as nal-irinotecan, 5-fluorouracil, and leucovorin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with chemotherapy (nal-irinotecan, 5-fluorouracil, and leucovorin) may work better in treating patients with biliary tract cancer compared to chemotherapy alone.
    Location: 5 locations

  • Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

    This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
    Location: 5 locations

  • Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651)

    The purpose of this study is to determine safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) for the following combinations: pembrolizumab plus binimetinib (Cohort A), pembrolizumab plus mFOLFOX7 (oxaliplatin 85 mg / m^2; leucovorin [calcium folinate] 400 mg / m^2; fluorouracil [5-FU] 2400 mg / m^2) (Cohort B), pembrolizumab plus mFOLFOX7 and binimetinib (Cohort C), pembrolizumab plus FOLFIRI (irinotecan 180 mg / m^2; leucovorin [calcium folinate]400 mg / m^2; 5-FU 2400 mg / m^2 over 46-48 hours) (Cohort D), and pembrolizumab plus FOLFIRI and binimetinib (Cohort E).
    Location: 6 locations

  • Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

    GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab, chemotherapy or other immune therapies. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.
    Location: 5 locations

  • Selinexor with Multiple Standard Chemotherapy or Immunotherapy 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 or immunotherapy 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 or immunotherapy 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

  • Study of IGM-8444 as a Single Agent and in Combination With Chemotherapy-based Regimens in Subjects With Solid Cancers

    This study is a first-in-human, Phase 1, multicenter, open-label study to determine the safety, tolerability and pharmacokinetics of IGM-8444 as a single agent and in combination with a chemotherapy-based regimen in patients with relapsed and / or refractory solid tumors.
    Location: 4 locations

  • 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: 4 locations

  • Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992 / KEYNOTE-992)

    This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.
    Location: 4 locations

  • FLOT and Chemoradiation before Surgery for the Treatment of Resectable Esophageal or Gastroesophageal Junction Cancer

    This phase II trial studies how well FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) and chemoradiation before surgery work in treating patients with esophageal or gastroesophageal junction cancer that can be removed by surgery (resectable). Drugs used in chemotherapy, such as 5-fluorouracil, leucovorin, oxaliplatin, docetaxel, 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. FLOT and chemoradiation before surgery may be an effective treatment for patients with esophageal or gastroesophageal junction cancer.
    Location: 4 locations