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 71
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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: 910 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 randomized 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: 560 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: 155 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

  • Study of IMMU-132 in HR+ / HER2- MBC (TROPICS-02)

    This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+ / HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.
    Location: 19 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

  • 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: 13 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: 11 locations

  • TSR-042 before Chemoradiotherapy and Surgery for the Treatment of Stage II or III Rectal Cancer with Mismatch Repair Deficiency or Microsatellite Instability

    This phase II trial studies how well TSR-042 before standard chemoradiotherapy and surgery works in treating patients with stage II or III rectal cancer with mismatch repair deficiency or microsatellite instability. 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

  • 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: 8 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

  • 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

  • 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

  • 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

  • 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

  • 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 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: 4 locations

  • SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

    The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.
    Location: 4 locations

  • Combination Chemotherapy and Pembrolizumab in Treating Patients with Previously Untreated Localized Gastric or Gastroesophageal Junction Cancer

    This phase II trial studies the side effects and how well combination chemotherapy and pembrolizumab work in treating patients with previously untreated cancer limited to the gastric or gastroesophageal junction. Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and epirubicin 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. 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. Giving combination chemotherapy and pembrolizumab may work better in treating patients with gastric or gastroesophageal junction cancer.
    Location: 4 locations

  • Trial of ZW25 in Patients With Advanced HER2-expressing Cancers

    This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and / or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK).
    Location: 4 locations

  • Capecitabine and Radiation Therapy with or without Pembrolizumab in Treating Participants with Resectable or Borderline Resectable Pancreatic Cancer

    The phase Ib / II trial studies the side effects of capecitabine and radiation therapy with or without pembrolizumab in treating participants with pancreatic cancer that can be removed by surgery. 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. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. It is not known if giving capecitabine and radiation therapy with or without pembrolizumab will work better in treating participants with pancreatic cancer.
    Location: 4 locations


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