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Esophageal Neoplasms clinical trials

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NCT ID: NCT01271322 Terminated - Clinical trials for Adenocarcinomas of the Esophagogastric Junction

Sequential FDG-PET (Positron Emission Tomography) and Induction Chemotherapy in Locally Advanced Adenocarcinoma of the Esophagogastric Junction (AEG)

HICON
Start date: October 2010
Phase: Phase 2
Study type: Interventional

Prospective, single-center, nonrandomized, explorative imaging study evaluating the value of PET as a predictor of histopathological response in metabolic non-responders Patients with resectable AEG (adenocarcinoma of the esophagogastric junction) type I and II (cT3/4 and/or cN+ and cM0) Metabolic non-responders, showing a <35% decrease of SUV (standardized uptake value) two weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to intensified taxane-based RCT (radiochemotherapy) before surgery. 18FDG-PET scans will be performed before (=Baseline) and after 14 days of standard neoadjuvant therapy as well after the first cycle of Taxotere/Cisplatin chemotherapy (=PET1) and at the end of intensified radiochemotherapy (PET2). Tracer uptake will be assessed semiquantitatively using standardized uptake values (SUV). The percentage difference Delta SUV=100(SUVBaseline-SUVPET1)/ SUVBaseline will be calculated and assessed as an early predictor of histopathological response. In a secondary analysis, the association between the difference SUVPET1 - SUVPET2 and histopathological response will be evaluated.

NCT ID: NCT01262183 Terminated - Clinical trials for Irresectable Squamous Cell or Adenocarcinoma of the Oesophagus

Radio-chemotherapy With or Without Panitumumab (Vectibix®) in Irresectable Squamous Cell Carcinoma or Adenocarcinoma of the Oesophagus

PANORAMIC
Start date: January 2011
Phase: Phase 2
Study type: Interventional

For esophageal cancer that can not be removed by surgery, the choice of treatment is a combination of chemotherapy and radiotherapy. We call this combination- (or concurrent) chemoradiotherapy. Chemotherapy is treatment with drugs that kill cancer cells. Both chemotherapy and radiotherapy make the tumour smaller and enhance each other's effect. The goal of treatment with chemotherapy and radiation therapy is to cure the cancer. Unfortunately only a small proportion of patients are cured with this treatment. Improvements in the outcome of treatment may be expected by using the so-called "targeted" treatments. With esophageal cancer, a protein (the epidermal growth factor receptor (this is a kind of trap), the EGFR), is present in many tumours. This protein causes the tumor to grow. Panitumumab is a drug that blocks the functioning of this receptor (catcher), so that possibly the growth and spread of esophageal cancer is prevented. The main objective of this trial is to see if survival of patients with inoperable esophageal cancer improves as panitumumab is added to standard treatment with chemoradiotherapy. It will also investigate whether patients tolerate the addition of panitumumab to the standard treatment. Also, the biological characteristics of the tumor will be examined. In a proportion of patients it will be determined how the enhancement of the cancer is visible on an FDG-PET scan before the start of treatment and how this changes during the treatment. It will be also be evaluated how this treatment affects the survival.

NCT ID: NCT01258868 Terminated - Lung Cancer Clinical Trials

Tumor Cell Vaccines With ISCOMATRIX Adjuvant and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas

Start date: December 1, 2010
Phase: Phase 1
Study type: Interventional

Background: - Recent research has shown that causing an immune response to tumor cells may help slow or stop the growth of tumors. One treatment that has come from this research involves collecting and modifying a cancer patient's tumor cells in the laboratory, then returning the cells to the patient as a vaccine to encourage the immune system to respond to them. Researchers are interested in testing tumor cell vaccines with an experimental drug called ISCOMATRIX , which can be added to a vaccine in order to elicit a stronger immune response in the body. ISCOMATRIX has not been approved for sale and use in any country and its use is still experimental, though it has been tested and used safely in other clinical studies. Researchers are also interested in determining whether the anti-inflammatory drug celecoxib will improve the body's immune reaction if given with the vaccine. Objectives: - To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and celecoxib in the treatment of lung and esophagus cancers. Eligibility: - Individuals at least 18 years of age who have primary small cell or non-small cell lung cancer, esophageal cancer, or pleural mesothelioma that can be removed by surgery. - Only individuals whose tumor cells are able to produce a tumor cell line for vaccine development will be eligible for treatment. Design: - Participants will be screened with a physical examination and medical history, and will have tumor tissue collected during their surgery to determine whether the tumor cells can be used to produce a vaccine. - Participants will take celecoxib twice daily for 7 days before having the first tumor cell vaccination. Participants will also have leukapheresis to collect blood cells for testing before the first vaccination. - Participants will receive one vaccine (which may be given in two shots) monthly for 6 months, and will continue to take celecoxib twice daily. One month after the 6th vaccine shot, participants will have another leukapheresis and skin test. If these tests show that a participant is responding to the vaccine, additional vaccines will be given every 3 months for up to 2 years. - Participants will have a physical exam and lab tests before each vaccination, blood samples and imaging studies every 3 months, and a skin test every 6 months. - Participants will have regular followup visits with imaging studies and blood samples for up to 5 years after the first vaccination, or until a new tumor develops.

NCT ID: NCT01249443 Terminated - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection

Start date: November 2013
Phase: Phase 1
Study type: Interventional

This phase I clinical trial is studying the side effects and the best dose of vorinostat when given together with paclitaxel and carboplatin in treating patients with metastatic or recurrent solid tumors and human immunodeficiency virus (HIV) infection. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may kill more tumor cells. NOTE: An administrative decision was made by NCI to halt further study of vorinostat in this specific patient population as of February 1, 2013. No patients remain on vorinostat. Going forward this study will determine the safety and tolerability of the paclitaxel and carboplatin combination in this patient population.

NCT ID: NCT01248299 Terminated - Clinical trials for Squamous Cell Carcinoma of Esophagus

Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.

E-DIS
Start date: January 2011
Phase: Phase 2
Study type: Interventional

Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.

NCT ID: NCT01182610 Terminated - Clinical trials for Gastroesophageal Adenocarcinoma

Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

Start date: April 2011
Phase: Phase 2
Study type: Interventional

This is an open-label, Phase II, single-stage study evaluating the use of panitumumab, paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal adenocarcinoma. The expectation is that this combination will both increase potential overall survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease potential surgical mortality by eliminating pre-operative radiation therapy.

NCT ID: NCT01145404 Terminated - Clinical trials for GastroEsophageal Cancer

Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer

GastroLap
Start date: June 2010
Phase: Phase 2
Study type: Interventional

Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a beneficial contribution to current treatment paradigms since preclinical data suggest that lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines, which may contribute to clinical benefit. The study described in this protocol has been designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to search for molecular correlates that may be associated with response to this compound. The majority of patients with metastatic gastric and gastro-esophageal cancer undergo first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes combined to a taxane), but the role of second-line chemotherapy has not yet been defined. Therefore, progression during or shortly after first-line chemotherapy is a medical condition no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and gastroesophageal cancer make these indications prime candidate for treatment with the dual ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.

NCT ID: NCT01143545 Terminated - Lung Cancer Clinical Trials

Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas

Start date: December 7, 2010
Phase: Phase 1
Study type: Interventional

Background: - Certain types of lung, esophageal, or thymic cancers and mesotheliomas have specific antigens (protein molecules) on their surfaces. Research studies have shown that giving a vaccine that contains antigens similar to these may cause an immune response, which may keep tumors from growing. Researchers are also interested in determining whether the chemotherapy drug cyclophosphamide and the anti-inflammatory drug celecoxib may help the vaccine work better, particularly in patients with lung cancer. Objectives: - To evaluate the safety and effectiveness of tumor cell vaccines in combination with cyclophosphamide and celecoxib in patients with cancers involving the chest. Eligibility: - Individuals at least 18 years of age who have had surgery for small cell or non-small cell lung cancer, esophageal cancer, thymoma or thymic carcinoma, and malignant pleural mesothelioma. Design: - Following recovery from surgery, chemotherapy, or radiation, participants will have leukapheresis to collect lymphocytes (white blood cells) for testing. - Participants will receive celecoxib and cyclophosphamide to take twice a day at home, 7 days before the vaccine. - Participants will have the vaccine in the clinical center (one or two shots per month for 6 months), and will stay in the clinic for about 4 hours after the vaccine. Participants will keep a diary at home of any side effects from the vaccine, and will continue to take cyclophosphamide and celecoxib. - One month after the sixth vaccine, participants will provide another blood sample for testing, and if the tests are satisfactory will return to the clinic every 3 months for 2 additional vaccines. - Participants will return to clinic for follow-up physical examinations, lab tests, and scans every 3 months for 2 years and then every 6 months for up to 3 years.

NCT ID: NCT01128387 Terminated - Cancer Clinical Trials

Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer

Start date: May 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET (Positron Emission Tomography) imaging to predict the degree of pathologic response. All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).

NCT ID: NCT01123473 Terminated - Gastric Cancer Clinical Trials

Epirubicin Hydrochloride, Cisplatin, and Fluorouracil or Capecitabine With or Without Lapatinib Ditosylate as First-Line Therapy in Treating Patients With Stomach Cancer or Gastroesophageal Junction Cancer

Start date: December 2010
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as epirubicin hydrochloride, cisplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving combination chemotherapy together with or without lapatinib ditosylate is more effective in treating patients with cancer of the stomach or gastroesophageal junction. PURPOSE: This randomized phase II trial is studying how well epirubicin hydrochloride, cisplatin, and fluorouracil or capecitabine works when given together with or without lapatinib ditosylate as first-line therapy in treating patients with stomach cancer or gastroesophageal junction cancer.