Clinical Trials Using Capecitabine

Clinical trials are research studies that involve people. The clinical trials on this list are studying Capecitabine. 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 74
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  • Platinum Based Chemotherapy or Capecitabine in Treating Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy

    This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin 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. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
    Location: 914 locations

  • Cisplatin, Carboplatin and Etoposide or Temozolomide and Capecitabine in Treating Patients with Neuroendocrine Carcinoma of the Gastrointestinal Tract or Pancreas That Is Metastatic or Cannot Be Removed by Surgery

    This phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, 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. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
    Location: 554 locations

  • Lower-Dose Chemoradiation in Treating Patients with Early-Stage Anal Cancer, the DECREASE Study

    This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.
    Location: 414 locations

  • Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients with Esophageal and Gastric Cancer that has Spread to a Limited Number of Other Places in the Body

    This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, 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. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer.
    Location: 179 locations

  • Capecitabine in Treating Patients with Metastatic Breast Cancer or Advanced / Metastatic Gastrointestinal Cancers

    This randomized phase II trial studies the side effects of capecitabine and how well it works when it is given dose-dense, fixed-dose as compared to standard dose in treating patients with breast cancer or gastrointestinal cancer that has spread from where it started to other places in the body or gastrointestinal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as 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.
    Location: 15 locations

  • DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

    This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: - cannot be removed by an operation - has spread to other parts of the body
    Location: 14 locations

  • Chemotherapy before or after Chemoradiation Followed by Surgery or Non-operative Management in Treating Patients with Previously Untreated Stage II-III Rectal Cancer

    This randomized phase II trial studies how well chemotherapy before or after chemoradiation followed by surgery or non-operative management works in treating patients with previously untreated stage II-III rectal cancer. Drugs used in chemotherapy, such as FOLFOX regimen (leucovorin calcium, fluorouracil, oxaliplatin), and CapeOX (oxaliplatin and capecitabine), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving chemotherapy before or after chemoradiation is more effective in treating rectal cancer. Additional chemotherapy may reduce the number of patients that require surgery.
    Location: 14 locations

  • Capecitabine and Neratinib in Treating Patients with HER2 Positive Stage IV Breast Cancer

    This phase Ib / II trial studies the side effects and best dose of capecitabine when given together with neratinib and to see how well it works in treating patients with HER2 positive stage IV breast cancer. Drugs used in chemotherapy, such as 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. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and neratinib may work better than capecitabine alone in treating patients with breast cancer.
    Location: 10 locations

  • Neratinib, Capecitabine, and Trastuzumab Emtansine in Treating Patients with HER2-Positive Breast Cancer That Has Spread to the Brain

    This phase II trial studies how well neratinib, capecitabine, and trastuzumab emtansine work in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to the brain. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as 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. Trastuzumab emtansine (T-DM1) is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Giving neratinib, capecitabine, and trastuzumab emtansine together may be an effective treatment for breast cancer.
    Location: 10 locations

  • Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

    This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: - Cannot be removed by an operation - Has spread to other parts of the body
    Location: 12 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: 10 locations

  • TSR-042 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 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). TSR-042 is a type of medication called an antibody, which is a protein made by the immune system to protect the body from harm. TSR-042 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

  • Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

    This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
    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

  • Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

    The study is a multi-center, un-blinded, randomized control study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.
    Location: 9 locations

  • Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585 / KEYNOTE-585)

    The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: - Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Overall Survival (OS), and Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and - Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.
    Location: 8 locations

  • Pembrolizumab, Trastuzumab, Fluorouracil, and Combination Chemotherapy as First Line Therapy in Treating Patients with HER2-Positive Stage IV Esophagogastric Cancer

    This phase II trial studies how well pembrolizumab works when given together with trastuzumab and combination chemotherapy as first line therapy in treating patients with HER2-positive stage IV esophagogastric cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab and trastuzumab, 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 combination chemotherapy, such as capecitabine, cisplatin, oxaliplatin, 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 pembrolizumab with trastuzumab and combination chemotherapy may work better as first line therapy in treating patients with esophagogastric cancer.
    Location: 8 locations

  • Docetaxel and Capecitabine in Treating Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

    This phase II trial studies the side effects and how well docetaxel and capecitabine work in treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that has come back or spread to other places in the body. Drugs used in chemotherapy, such as docetaxel 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.
    Location: 6 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

  • Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA / MBC

    CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with taxane-naïve, HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA / MBC). The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine, based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). Approximately 125 patients will be enrolled.
    Location: 5 locations

  • A Multi-Center Study of SM-88 in Subjects With 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

  • Selinexor with Multiple Standard Chemotherapy Regimens in Treating Patients with Advanced Malignancies

    This phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy regimens in treating patients with malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Studying selinexor with different standard chemotherapy regimens may help doctors learn the side effects and best dose of selinexor that can be given with different types of treatments in one study.
    Location: 5 locations

  • A Safety and Efficacy Study of ZW25 Plus Combination Chemotherapy in HER2-expressing Gastroesophageal Adenocarcinoma

    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 plus physician's choice of combination chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (GEA). Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA.
    Location: 4 locations

  • Study of M3814 in Combination With Capecitabine and Radiotherapy in Rectal Cancer

    The main purpose of the study is to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) of M3814 in combination with capecitabine and radiotherapy (RT) in Phase Ib and to evaluate the efficacy of M3814 in terms of Pathological Clinical Response (pCR) / Clinical Complete Response (cCR) when administered in combination with capecitabine and RT versus placebo, capecitabine, and RT in Phase II.
    Location: 6 locations

  • Tucatinib, Trastuzumab, and Capecitabine in Treating Patients with HER2 Positive Breast Cancer with Leptomeningeal Metastases

    This phase II trial studies how well tucatinib, trastuzumab, and capecitabine work in treating patients with HER2 positive breast cancer that has spread to the leptomeninges (leptomeningeal metastases). Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. Drugs used in chemotherapy, such as 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. Giving tucatinib, trastuzumab, and capecitabine may help to control leptomeningeal disease and improve survival in patients with breast cancer.
    Location: 4 locations


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