Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01088620
Status:
SUSPENDED
Last Update Posted:
2013-03-14
First Post:
2010-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077544', 'term': 'Panitumumab'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'whyStopped': 'the DSMB stopped the trial due to unacceptable side effects in the experimental arm which has not yet been verified', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-13', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival rate at 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Determination of the tumour response', 'timeFrame': '6 months'}, {'measure': 'Duration of response', 'timeFrame': '6 months'}, {'measure': 'Overall survival', 'timeFrame': '6 month'}, {'measure': 'Adverse effects / toxicity', 'timeFrame': '6 months'}, {'measure': 'Quality of life assessment', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSCLC', 'Stage IIIb or IV', 'Nonsquamous', 'KRAS-Wildtype'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '26094080', 'type': 'DERIVED', 'citation': 'Schuette W, Behringer D, Stoehlmacher J, Kollmeier J, Schmager S, Fischer von Weikersthal L, Schumann C, Buchmann J. CHAMP: A Phase II Study of Panitumumab With Pemetrexed and Cisplatin Versus Pemetrexed and Cisplatin in the Treatment of Patients With Advanced-Stage Primary Nonsquamous Non-Small-Cell Lung Cancer With Particular Regard to the KRAS Status. Clin Lung Cancer. 2015 Nov;16(6):447-56. doi: 10.1016/j.cllc.2015.05.009. Epub 2015 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with pemetrexed and cisplatin) in relation to the standard combination in patients with a KRAS wild-type stage IIIB or IV primary nonsquamous non-small cell lung cancer. It is expected that the progression free survival rate at 6 months is improved by the targeted regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of inoperable stage IIIB or IV primary pulmonary nonsquamous NSCLC (according to UICC staging valid until 2008)\n* Sufficient representative sample material for KRAS analysis\n* Wild-type KRAS\n* Informed consent of the patient\n* Aged at least 18 years\n* WHO Performance Status 0-2\n* At least one unidimensional, measurable tumour parameter according to RECIST\n* Life expectancy of al least 12 weeks\n* Adequate haematological, hepatic, renal and metabolic function parameters:\n\n * Leukocytes \\> 3000/mm³, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, Creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5 x upper limit of normal\n * Bilirubin ≤ 1.5 x upper limit of normal, GOT-GPT ≤ 2.5 x upper limit of normal in absence of liver metastases, or ≤ 5 x upper limit of normal in presence of liver metastases, AP ≤ 5 x upper limit of normal\n * Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal\n\nExclusion Criteria:\n\n* Prior chemotherapy\n* Clinically manifest, uncontrolled brain metastases\n* Prior radiotherapy of the parameters to be measured\n* Peripheral neuropathy NCI grade \\> 1\n* Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.\n* Subject (male or female) is not willing 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).\n* Serious concurrent diseases.\n* Major surgery within the last 4 weeks before recruitment\n* On-treatment participation in a clinical study in the period 30 days prior to inclusion.\n* Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.\n* Ongoing or active infection, including active tuberculosis or known infection with human immunodeficiency virus.\n* Superior vena cava syndrome contraindicating hydration.\n* History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.\n* Patient with mild to moderate renal insufficiency who are unable to interrupt salicylates (like aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDS) for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long-acting agents such as piroxicam). Exception: Low dose aspirin (acetyl salicylic acid) intake up to 150 mg per day is permitted without interruption.\n* Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures\n* Inability or unwillingness to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures\n* Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free\n* Known allergic reactions on study medication'}, 'identificationModule': {'nctId': 'NCT01088620', 'briefTitle': 'Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'WiSP Wissenschaftlicher Service Pharma GmbH'}, 'officialTitle': 'CHAMP - An Open-label, Randomised, Multicentre, Phase II Clinical Study of Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Stage IIIB or IV Primary Nonsquamous Non-small Cell Lung Cancer, With Particular Regard to the KRAS Status', 'orgStudyIdInfo': {'id': 'WISP_AG47'}, 'secondaryIdInfos': [{'id': '2009-014677-41', 'type': 'EUDRACT_NUMBER'}, {'id': 'GMIHO-006/2008', 'type': 'OTHER', 'domain': 'GMIHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panitumumab plus pemetrexed and cisplatin (PemCisP)', 'interventionNames': ['Drug: Panitumumab', 'Drug: Pemetrexed', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pemetrexed and cisplatin (PemCis)', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Panitumumab', 'type': 'DRUG', 'otherNames': ['Vectibix'], 'description': 'Panitumumab 9 mg/kg BW will be administered IV every 3 weeks (q3w) for a maximum of four cycles.\n\nIn case of CR, PR or SD status at the end of the combination treatment, a panitumumab single drug treatment, consisting of 9 mg/kg BW administered every 3 weeks, will be performed until detection of disease progression.', 'armGroupLabels': ['Panitumumab plus pemetrexed and cisplatin (PemCisP)']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta'], 'description': 'Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.', 'armGroupLabels': ['Panitumumab plus pemetrexed and cisplatin (PemCisP)', 'Pemetrexed and cisplatin (PemCis)']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.', 'armGroupLabels': ['Panitumumab plus pemetrexed and cisplatin (PemCisP)', 'Pemetrexed and cisplatin (PemCis)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92224', 'city': 'Amberg', 'country': 'Germany', 'facility': 'Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gesundheitszentrum St. Marien GmbH', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitätsklinikum Charité - Campus Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Benjamin Franklin Medizinische Klinik m. S. Hämatologie und Onkologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14165', 'city': 'Berlin', 'country': 'Germany', 'facility': 'HELIOS Klinikum Emil von Behring - Lungenklinik Heckeshorn', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Augusta-Kranken-Anstalt gGmbH', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '53113', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Johanniter-Krankenhaus Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '51109', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Kliniken der Stadt Köln, Krankenhaus Merheim', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '03048', 'city': 'Cottbus', 'country': 'Germany', 'facility': 'Carl-Thiem-Klinikum Cottbus gGmbH', 'geoPoint': {'lat': 51.75769, 'lon': 14.32888}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Medizinische Fakultät Carl Gustav Carus der Technischen Universität Dresden Medizinische Klinik 1', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '47166', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Katholisches Klinikum Duisburg/St. Johannes-Hospital', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '15236', 'city': 'Frankfurt (Oder)', 'country': 'Germany', 'facility': 'Klinikum Frankfurt (Oder) GmbH', 'geoPoint': {'lat': 52.34714, 'lon': 14.55062}}, {'zip': '22927', 'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'Krankenhaus Großhansdorf GmbH Onkologischer Schwerpunkt', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Krankenhaus - Martha-Maria Halle-Dölau GmbH', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin I', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '07740', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena, Klinik für Innere Medizin I', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '96317', 'city': 'Kronach', 'country': 'Germany', 'facility': 'Onkologische Schwerpunktpraxis Dr. Stauch', 'geoPoint': {'lat': 50.23963, 'lon': 11.33308}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'UK-SH, Campus Lübeck, Med. Klinik III', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'LMU-Klinikum der Universität München, Medizinische Klinik München-Innenstadt', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '45657', 'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'Oncologianova GmbH', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Uniklinikum Ulm, Klinik für Innere Medizin II, Pneumologie', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Wolfgang Schütte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krankenhaus Martha-Maria Halle-Dölau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WiSP Wissenschaftlicher Service Pharma GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}