关于胃癌分子靶向治疗的临床研究.doc

1. A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer（recruiting participants）Purpose This 2 arm study will compare the efficacy and safety of Avastin versus placebo, in combination with Xeloda and cisplatin, in patients who have received no prior treatment for advanced or metastatic gastric cancer. Patients will be randomized to receive either Avastin 7.5mg/kg iv or placebo iv, in combination with Xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle, and cisplatin 80mg/m2 every 3 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.Condition Intervention Phase Gastric CancerDrug: bevacizumab AvastinDrug: capecitabine XelodaDrug: cisplatinDrug: PlaceboPhase IIIStudy Type:InterventionalStudy Design:Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy StudyOfficial Title:A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Chinese Patients With Advanced Gastric Cancer.2. Pre-Operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ AdenocarcinomaThis study is currently recruiting participants. Verified by Memorial Sloan-Kettering Cancer Center, July 2009First Received: August 15, 2008 Last Updated: July 1, 2009 History of Changes Sponsors and Collaborators: Memorial Sloan-Kettering Cancer CenterGenentechInformation provided by: Memorial Sloan-Kettering Cancer CenterClinicalT Identifier: NCT00737438 Purpose This study is being done to find out how effective a new treatment strategy is on your cancer. In this strategy, the response your tumor has to the first cycle of therapy will help select the next treatments. We also will find out the effects, both good and/or bad, a drug called bevacizumab has on you and your tumor when given with chemotherapy.Condition Intervention Phase Esophageal CancerGastric CancerDrug: epirubicin, cisplatin, capecitabine, bevacizumab, docetaxel and irinotecanPhase IIStudy Type:InterventionalStudy Design:Treatment, Open Label, Single Group Assignment, Efficacy StudyOfficial Title:A Phase II Study of Pre-Operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma3.Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric CancerThis study is ongoing, but not recruiting participants. First Received: August 15, 2005 Last Updated: May 12, 2009 History of Changes Sponsors and Collaborators: Dana-Farber Cancer InstituteBristol-Myers SquibbMassachusetts General HospitalBeth Israel Deaconess Medical CenterInformation provided by: Dana-Farber Cancer InstituteClinicalT Identifier: NCT00130689 Purpose The purpose of this study is to determine the response rate of cetuximab in patients with advanced esophageal or gastric cancer.The secondary purposes are to determine the safety and to evaluate the duration of response in patients treated with cetuximab.Condition Intervention Phase Esophageal CancerGastric CancerNeoplasm MetastasisDrug: CetuximabPhase IIStudy Type:InterventionalStudy Design:Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy StudyOfficial Title:A Phase II Trial of Cetuximab in Unresectable or Metastatic Esophageal and Gastric Carcinoma4.Lapatinib（拉帕替尼）in Treating Patients With Locally Advanced or Metastatic Stomach CancerThis study is ongoing, but not recruiting participants. First Received: February 7, 2005 Last Updated: July 23, 2008 History of Changes Sponsors and Collaborators: Southwest Oncology GroupNational Cancer Institute (NCI)Information provided by: National Cancer Institute (NCI)ClinicalT Identifier: NCT00103324 Purpose RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic stomach cancer.Condition Intervention Phase Gastric CancerDrug: lapatinib ditosylatePhase IIStudy Type:InterventionalStudy Design:Treatment, Open LabelOfficial Title:Phase II Study of GW572016 (NSC #727989) as First Line Therapy in Patients With Advanced or Metastatic Gastric Cancer5. Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric CancerThis study is ongoing, but not recruiting participants. First Received: October 31, 2006 Last Updated: December 5, 2008 History of Changes Sponsors and Collaborators: Dana-Farber Cancer InstituteBrigham and Womens HospitalMassachusetts General HospitalGenentechInformation provided by: Dana-Farber Cancer InstituteClinicalT Identifier: NCT00394433 Purpose The purpose of this research study is to determine if the combination of docetaxel, cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is believed to stop the formation of new blood vessels that carry nutrients to tumors. Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin and irinotecan are traditional chemotherapy agents that have been tested together in another clinical trial for esophageal and gastric cancer. Of the 40 patients on this trial, 60% of the patients showed a response of some kind and the regimen was well tolerated. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.6. Antiangiogenic Factors in Gastric CancerThis study is currently recruiting participants. Verified by National Cancer Center, Korea, August 2008First Received: August 13, 2008 Last Updated: August 14, 2008 History of Changes Sponsored by: National Cancer Center, KoreaInformation provided by: National Cancer Center, KoreaClinicalT Identifier: NCT00735566 Purpose Endogenous antiangiogenic factors are related with gastric cancer progression.Condition Gastric CancerStudy Type:ObservationalStudy Design:Cohort, ProspectiveOfficial Title:The Role of Endogenous Antiangiogenic Factors in Gastric Cancer ProgressionResource links provided by NLM:MedlinePlus related topics: Cancer StomachCancer U.S. FDA Resources Condition Intervention Phase Esophageal CancerStomach CancerDrug: BevacizumabDrug: DocetaxelDrug: CisplatinDrug: IrinotecanPhase IIStudy Type:InterventionalStudy Design:Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy StudyOfficial Title:A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer7. A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric CancerThis study is currently recruiting participants. Verified by ACT Biotech, Inc, August 2009First Received: July 30, 2009 Last Updated: August 26, 2009 History of Changes Sponsored by: ACT Biotech, IncInformation provided by: ACT Biotech, IncClinicalT Identifier: NCT00952497 Purpose The objectives of this study are to evaluate the anti-tumor activity, safety, and tolerability of telatinib when used in combination with chemotherapy (capecitabine and cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary objective is to assess progression free survival (PFS) in subjects receiving telatinib in combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and biomarkers.Condition Intervention Phase Gastric CancerDrug: Cisplatin, Capecitabine, TelatinibPhase IIStudy Type:InterventionalStudy Design:Treatment, Open Label, Single Group Assignment, Safety/Efficacy StudyOfficial Title:A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination With Chemotherapy as First-Line Therapy in Subjects With Advanced Gastric Cancer8. Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric CancerThis study is currently recruiting participants. Verified by FDA Office of Orphan Products Development, July 2008First Received: January 30, 2007 Last Updated: July 1, 2008 History of Changes Sponsored by: FDA Office of Orphan Products DevelopmentInformation provided by: FDA Office of Orphan Products DevelopmentClinicalT Identifier: NCT00429078 Purpose This study proposes to determine the safety and tolerability of 2nd generation designer T cells in patients with gastric cancer.Designer T cells are prepared by removing white blood cells from the participant, and then modifying these cells so that they recognize tumor antigen(CEA). These modified cells are then re infused back into the participant so that they can attack and kill tumor cells.Eligibility for this study is diagnosis of carcinoma of the stomach with failure to respond to standard curative therapy. Tumors must express CEA as demonstrated by elevated serum CEA 10ng/ml and be measurable radiologically or by physical exam.Condition Intervention Phase Gastric CancerGenetic: 2nd Generation Designer T CellsPhase IStudy Type:InterventionalStudy Design:Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy StudyOfficial Title:Phase I Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer9. Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer PatientsThis study is currently recruiting participants. Verified by AstraZeneca, August 2009First Received: August 11, 2009 Last Updated: August 18, 2009 History of Changes Sponsored by: AstraZenecaInformation provided by: AstraZenecaClinicalT Identifier: NCT00960349 Purpose The primary objective of the study is to assess the safety and tolerability of cediranib in combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese patients with previously untreated locally advanced or metastatic unresectable gastric cancer (GC).Condition Intervention Phase Gastric CancerDrug: CediranibDrug: CisplatinDrug: S-1Drug: CapecitabinePhase IStudy Type:InterventionalStudy Design:Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety StudyOfficial Title:A Phase I, Open-label, Non-randomized Study, to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With Cisplatin Plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese Patients With Previously Untreated Locally Advanced or Metastatic Unresectable Gastric Cancer10. Cetuximab, Cisplatin, and Irinotecan in Treating Patients With Metastatic Esophageal Cancer, Gastroesophageal Junction Cancer, or Gastric Cancer That Did Not Respond to Previous Irinotecan and CisplatinThis study is currently recruiting participants. Verified by National Cancer Institute (NCI), July 2009First Received: November 9, 2006 Last Updated: July 22, 2009 History of Changes Sponsors and Collaborators: Memorial Sloan-Kettering Cancer CenterNational Cancer Institute (NCI)Information provided by: National Cancer Institute (NCI)ClinicalT Identifier: NCT00397904 Purpose RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin and irinotecan may kill more tumor cells.PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin and irinotecan works in treating patients with metastatic esophageal cancer, gastroesophageal junction cancer, or gastric cancer that did not respond to previous irinotecan and cisplatin.Condition Intervention Phase Esophageal CancerGastric CancerBiological: cetuximabDrug: cisplatinDrug: irinotecan hydrochlorideOther: immunohistochemistry staining methodOther: laboratory biomarker analysisProcedure: biopsyPhase IIStudy Type:InterventionalStudy Design:Treatment, Non-Randomized, Open LabelOfficial Title:Phase II Trial of Cetuximab Plus Cisplatin and Irinotecan in Patients With Irinotecan and Cisplatin-Refractory Metastatic Esophageal and Gastric Cancer12. Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric CancerThis study is currently recruiting participants. Verified by Dana-Farber Cancer Institute, July 2009First Received: May 29, 2009 Last Updated: July 29, 2009 History of Changes Sponsors and Collaborators: Dana-Farber Cancer InstituteMassachusetts General HospitalSarah Cannon Research InstituteTexas Oncology Cancer CenterGenentechInformation provided by: Dana-Farber Cancer InstituteClinicalT Identifier: NCT00911820 Purpose There is no clear standard of care for metastatic stomach or esophageal cancer in the United States. The purpose of this research study is to determine the differences between two regimens of chemotherapy; Arm A: PCA (Cisplatin, Irinotecan and Bevacizumab) and Arm B: TPCA (Docetaxel, Cisplatin, Irinotecan and Bevacizumab).Docetaxel, Cisplatin, and Irinotecan are traditional chemotherapy drugs. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body). Bevacizumab is believed to stop the formation of new blood vessels that carry nutrients to tumors. Both of the chemotherapy regimens (PCA and TPCA) have been studied in patients with esophageal and gastric cancer, and we are trying to determine if one regimen will keep your cancer from growing and improve how long you can live.Condition Intervention Phase Esophageal CancerGastric CancerStomach CancerDrug: BevacizumabDrug: CisplatinDrug: IrinotecanDevice: DocetaxelPhase IIStudy Type:InterventionalStudy Design:Treatment, Randomized, Open Label, Parallel Assignment, Efficacy StudyOfficial Title:A Randomized, Multicenter, Phase II Trial of Cisplatin, Irinotecan and Bevacizumab (PCA) vs. Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer13. Sunitinib, Irinotecan, Fluorouracil, and Leucovorin In Treating Patients With Advanced Stomach Cancer or Gastroesophageal CancerThis study is currently recruiting participants. Verified by National Cancer Institute (NCI), June 2009First Received: August 31, 2007 Last Updated: June 9, 2009 History of Changes Sponsors and Collaborators: Roswell Park Cancer InstituteNational Cancer Institute (NCI)Information provided by: National Cancer Institute (NCI)ClinicalT Identifier: NCT00524186 Purpose RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with combination chemotherapy may kill more tumor cells.PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib when given together with irinotecan, fluorouracil, and leucovorin in treating patients with advanced stomach cancer or gastroesophageal cancer.Condition Intervention Phase Esophageal CancerGastric CancerDrug: fluorouracilDrug: irinotecan hydrochlorideDrug: leucovorin calciumDrug: sunitinib malateOther: flow cytometryOther: pharmacological studyPhase IStudy Type:InterventionalStudy Design:Treatment, Open LabelOfficial Title:Phase I Study of Sunitinib With FOLFIRI (Irinotecan, 5-Fluorouracil and Leucovorin) for Advanced Gastroesophageal Cancers14. Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And LapatinibThis study is currently recruiting participants. Verified by GlaxoSmithKline, July 2009First Received: September 6, 2007 Last Updated: July 23, 2009 History of Changes Sponsored by: GlaxoSmithKlineInformation provided by: GlaxoSmithKlineClinicalT Identifier: NCT00526669 Purpose The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.Condition Intervention Phase Gastric CancerGastro Esophageal(GE)Junction CancerDrug: Lapatinib and CapecitabinePhase IIStudy Type:InterventionalStudy Design:Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy StudyOfficial T