PiCCA Study (Panitumumab in Combination With Cisplatin/Gemcitabine)

Size: px

Start display at page:

Download "PiCCA Study (Panitumumab in Combination With Cisplatin/Gemcitabine)"

Barrie Kennedy
6 years ago
Views:

Page 1 of 6 Home Search Study Topics Glossary Search Study 1 of 1 for search of: NCT01320254 Previous Study Return to Search Results Next Study Full Text View Tabular View No Study Results Posted

1 Page 1 of 6 Home Search Study Topics Glossary Search Study 1 of 1 for search of: NCT Previous Study Return to Search Results Next Study Full Text View Tabular View No Study Results Posted Related Studies PiCCA Study ( in Combination With Cisplatin/Gemcitabine) This study is currently recruiting participants. Verified November 2011 by Hannover Medical School First Received on March 21, Last Updated on November 10, 2011 History of Changes Sponsor: Hannover Medical School Collaborator: Hannover Clinical Trial Center GmbH Information provided by (Responsible Party): Hannover Medical School ClinicalTrials.gov Identifier: NCT Purpose The purpose of this study is to determine the efficacy of panitumumab plus cisplatin/gemcitabine (CisGem) combination chemotherapy in KRAS wild-type biliary tract cancer patients without systemic pre-treatment, compared to the historical data and to the randomised control group without the antibody, which verifies the historically based assumption. Condition Intervention Phase Cholangiocarcinomas Drug: Cisplatin, Gemcitabine, Drug: Cisplatin, Gemcitabine Phase 2 Study Type: Study Design: Official Title: Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment in Combination With Cisplatin/Gemcitabine Chemotherapy in Patients With Cholangiocarcinomas - a Randomized Clinical Phase II Study Resource links provided by NLM: MedlinePlus related topics: Cancer Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride U.S. FDA Resources Further study details as provided by Hannover Medical School: Primary Outcome Measures:

2 Page 2 of 6 progression-free survival rate [ Time Frame: 6 months ] [ Designated as safety issue: No ] The progression-free survival rate at six months (primary endpoint) is defined as the number of patients recorded to be free of progression (according to RECIST) at this time point, divided by the number of patients randomized to the respective arm. Secondary Outcome Measures: Tumor response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] Tumor response according to RECIST criteria within the first 48 weeks of treatment Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ] Progression-free survival (PFS) will be defined as the time from randomisation to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation). Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ] The duration of overall survival (OS) will be determined by measuring the time interval from randomisastion to the date of death or last observation (censored). Number of Participants with Adverse Events as a Measure of Toxicity/Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] Translational research [ Time Frame: 3 years ] [ Designated as safety issue: No ] assessment/ correlation of tumor response with KRAS (mandatory) alterations in cholangiocarcinomas and gallbladder cancer (EGFR, PTEN, BRAF)through optional translational research Estimated Enrollment: 92 Study Start Date: June 2011 Estimated Study Completion Date: April 2014 Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure) Arms Experimental: Cisplatin, Gemcitabine and Experimental Arm with cisplatin 25mg/sq.m. at day 1 + 8, gemcitabine 1000mg/ sq.m.at day and panitumumab 9mg/kg BW at day 1. Cycle will be repeated every 3 weeks. Active Comparator: Cisplatin and Gemcitabine Cisplatin 25mg/sq.m. at day and Gemcitabine 1000 mg/sq.m. at day Cycle will be repeated every 3 weeks. Assigned Interventions Drug: Cisplatin, Gemcitabine, Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day mg/kg BW at day 1 Other Names: Vectibix () Gemzar (Gemcitabine) Cisplatin 0.5mg/ml solution medac (Cisplatin) Drug: Cisplatin, Gemcitabine Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day Other Names: Gemzar (Gemcitabine) Cisplatin 0.5mg/ml solution medac (Cisplatin)

3 Page 3 of 6 Show Detailed Description Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 18 Years and older Both No Criteria Inclusion Criteria: Signed,dated informed consent before start of specific protocol procedures Histologically/cytologically documented diagnosis of cholangiocarcinoma or gall bladder carcinoma At least one measurable site of disease following RECIST V. 1.1 criteria Wild-type KRAS status as assessed by standardized PCR Unresectable, locally advanced or metastatic disease Age > 18 years old ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks Adequate bone marrow, liver (with stenting for any obstruction, if required) and renal function (lab. assessment within 7 days prior to screening): Hemoglobin > 10.0 g/dl Leukocyte count > 3.000/mm3 ; absolute neutrophil count (ANC) > 1.500/mm3 Platelet count /mm³ Total bilirubin < 5,0 times the upper limit of normal ALT and AST < 3 x upper limit of normal Alkaline phosphatase < 5 x ULN PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 60 ml/min Magnesium lower limit of normal; calcium lower limit of normal The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations Negative pregnancy test performed within 7 days prior to the start of treatment, and willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly) Exclusion Criteria: KRAS mutation Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. History of HIV infection or chronic hepatitis B or C Active clinically serious infections (> grade 2 NCI-CTC version 3.0) Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex (patellar tendon reflex) Symptomatic or known brain metastases.a scan to confirm the absence of brain metastases is not required -Patients with seizure disorder requiring medication (such as steroids or anti- epileptics) History of organ allograft Patients with evidence or history of bleeding diathesis Patients undergoing renal dialysis

4 Page 4 of 6 Patients with second primary cancer,except adequately treated basal skin cancer or carcinoma in-situ of the cervix Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study No prior anti-cancer chemotherapy,radiotherapy(excluding palliative radiotherapy administered more than 4 weeks prior to study entry),endocrine or immunotherapy Investigational drug therapy outside of this trial during or within 4weeks of study entry Major surgery within 4 weeks of starting the study and patients must have recovered from effects of major surgery Prior anti-egfr therapy Autologous bone marrow transplant or stem cell rescue within 4 months of study Breast-feeding patients Substance abuse, medical, psychological or social conditions that may interfere with the patient's understanding of the informed consent procedure, participation in the study or evaluation of the study results Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT Contacts Contact: Arndt Vogel, PD Dr. MD vogel.arndt@mh-hannover.de Locations Germany Esslingen Hospital Esslingen, Baden-Wuerttemberg, Germany, National Centre for Tumor Diseases (NCT) Heidelberg, Baden-Wuerttemberg, Germany, Contact: Henning Schulze-Bergkamen, PD Dr. MD henning.schulze@nct Principal Investigator: Henning Schulze-Bergkamen, PD Dr. MD Sub-Investigator: Jürgen Kraus, Dr. MD Sub-Investigator: Stefan Bauer, Dr. MD Sub-Investigator: Stefan-Ezechiel Welte, Dr. MD Sub-Investigator: Karl-Roland Ehrenberg, Dr. MD Sub-Investigator: Stephan Nachtigall, Dr. MD Sub-Investigator: Christian Rupp, Dr. MD Sub-Investigator: Michael Schmitz, Dr. MD University Hospital Mannheim Mannheim, Baden-Wuerttemberg, Germany, University Hospital Tuebingen Tuebingen, Baden-Wuerttemberg, Germany, Contact: Michael Bitzer, Prof. Dr. MD michael.bitzer@uni-tuebingen.de Principal Investigator: Michael Bitzer, Prof. Dr. MD Sub-Investigator: Ulrich Lauer, Dr. MD Sub-Investigator: Ulrike Schempf, Dr. MD Sub-Investigator: Siri Göpel, Dr. MD Sub-Investigator: Christoph Müller, Dr. MD University Hospital Regensburg Regensburg, Bavaria, Germany, Charité Berlin Berlin, Berlin-City, Germany, University Hospital Hamburg-Eppendorf Hamburg, Free City of Hamburg, Germany, Contact: Andreas Block, Prof. Dr. MD block@uke.uni-hamburg.de Principal Investigator: Andreas Block, Prof. Dr. MD Sub-Investigator: Oliver Stöltzing, Dr. MD Sub-Investigator: Christian Frenzel, Dr. MD Sub-Investigator: Dirk Arnold, Prof. Dr. MD Medical School Hannover

5 Page 5 of 6 Sponsors and Collaborators Hannover Medical School Hannover Clinical Trial Center GmbH Investigators More Information No publications provided Hannover, Lower Saxony, Germany, Contact: Arndt Vogel, PD DR. MD vogel.arndt@mh-hannover.de Contact: Vogel Principal Investigator: Arndt Vogel, PD Dr. MD Sub-Investigator: Nisar Malek, Prof. Dr. University Hospital Essen Not yet recruiting Essen, Northrhine-Westfalia, Germany, Contact: Tanja Trarbach, Dr. MD tanja.trarbach@uk-essen.de Principal Investigator: Tanja Trarbach, Dr. MD Sub-Investigator: Johannes Meiler, Dr. MD Sub-Investigator: Martin Schuler, Dr. MD Sub-Investigator: Marit Ahrens, Dr. MD Sub-Investigator: Stefan Kasper, Dr. MD University Hospital Mainz Mainz, Rhineland-Palatinate, Germany, Magdeburg Hospital Magdeburg, Saxony-Anhalt, Germany, Contact: Christoph Kahl, PD Dr. MD christoph.kahl@klinikum-magdebur Principal Investigator: Christoph Kahl, PD Dr. MD Sub-Investigator: Karsten Ridwelski, Dr.MD Sub-Investigator: Carsten Roll, Dr. MD Sub-Investigator: Norbert Schmidt, Dr. MD Sub-Investigator: Stephan Rudolph, Dr. MD Sub-Investigator: Antje Kahlweiß, Dr. MD Sub-Investigator: Maria Klarfeld, Dr. MD Principal Investigator: Tanja Trarbach, Dr. MD University Hospital, Essen Principal Investigator: Hanno Ries, Prof. Dr. MD Charité Berlin Principal Investigator: Michael Bitzer, Prof. Dr. MD University Hospital Tuebingen Principal Investigator: Kirsten Merx, Dr. MD University Hospital Mannheim Principal Investigator: Henning Schulze-Bergkamen, PD Dr. MD National Centre for Tumor Diseases ( Principal Investigator: Frank Klebl, PD Dr. MD University Hospital Regensburg Principal Investigator: Andreas Block, Prof. Dr. Universitätsklinikum Hamburg-Eppen Principal Investigator: Michael Geißler, Prof. Dr. MD Esslingen Hospital Principal Investigator: Christoph Kahl, PD Dr. Magdeburg Hospital Principal Investigator: Markus Möhler, Prof: Dr. MD University Hospital Mainz Study Chair: Arndt Vogel, PD Dr. MD Hannover Medical School Responsible Party: Hannover Medical School, MD ClinicalTrials.gov Identifier: NCT History of Changes Other Study ID Numbers: EudraCT-Nr.: Study First Received: March 21, 2011 Last Updated: November 10, 2011 Health Authority: Germany: Paul-Ehrlich-Institut Keywords provided by Hannover Medical School: Palliative treatment Cisplatin Additional relevant MeSH terms: Cholangiocarcinoma Cisplatinum Gemcitabine Vectibix Pharmacologic Actions

6 Page 6 of 6 Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gemcitabine Cisplatin Antibodies, Monoclonal Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors ClinicalTrials.gov processed this record on July 22, 2012 Contact Help Desk Lister Hill National Center for Biomedical Communications, U.S. National Library of Medicine, U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act

Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients

1 von 5 23.11.2011 10:52 Home Search Study Topics Glossary Full Text View Tabular View No Study Results Posted Related Studies Panitumumab After Resection of Liver Metastases From Colorectal Cancer in