Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT01374620
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2011-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2011-06-14', 'studyFirstSubmitQcDate': '2011-06-15', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the iv paclitaxel maximum tolerated dose and recommended dose in association with a fixed dose of oral cyclophosphamide', 'timeFrame': '28 days = cycle 1', 'description': 'A DLT is defined below:\n\nHematological toxicity:\n\n* Polunuclear neutrophils \\< 500/mm3 for more than 7 days\n* Febrile neutropenia (Polunuclear neutrophils \\< 1 000/mm3 and fever \\> or = 38.5°C) or documented infection\n* Thrombopenia (Platelets \\< 25 000/mm3)\n* Impossibility to administer D8 or D15 due to hematological critera\n\nNon-hematological toxicity:\n\nAny grade 3 or 4 toxicity related to study treatment, with the exception of fatigue and alopecia'}], 'secondaryOutcomes': [{'measure': 'Description of the nature of adverse events', 'timeFrame': 'During the study treatment, an expected average of 2 months', 'description': 'According to the NCI-CTCAE scale v4.0'}, {'measure': 'Evaluation of objective response after 2 cycles', 'timeFrame': 'After 2 cycles = 2 months', 'description': 'Objective response (complete response, partial response and stable disease) according to RECIST 1.1 criteria'}, {'measure': 'Estimation of the free-progression median time', 'timeFrame': 'Until disease progression', 'description': 'Time between the inclusion and the disease progression (clinical or radiological)'}, {'measure': 'Calculation of the Growth Modulation Index (GMI)', 'timeFrame': 'Until disease progression', 'description': 'Time to progression on study treatment and time to progression on prior treatment'}, {'measure': 'Evaluation of the correlation between clinical response and biological parameters', 'timeFrame': 'Day 1, 8, 15, 21 of cycle 1 and cycle 2', 'description': 'Biological parameters related to angiogenesis'}, {'measure': 'Description of the severity of adverse events', 'timeFrame': 'During the study treatment, an expected average of 2 months', 'description': 'According to the NCI-CTCAE scale v4.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '30064401', 'type': 'DERIVED', 'citation': 'Pannier D, Adenis A, Bogart E, Dansin E, Clisant-Delaine S, Decoupigny E, Lesoin A, Amela E, Ducornet S, Meurant JP, Le Deley MC, Penel N. Once weekly paclitaxel associated with a fixed dose of oral metronomic cyclophosphamide: a dose-finding phase 1 trial. BMC Cancer. 2018 Jul 31;18(1):775. doi: 10.1186/s12885-018-4678-x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.', 'detailedDescription': 'The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide for cancer which present no therapeutic solution'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with cancer histologically proved\n* No other therapeutic proposal after discussion in multidisciplinary consultation\n* Radiological evidence of the evolving nature of the disease\n* Measurable disease with at least one measurable lesion according to the criteria RECIST 1.1\n* At least 28 days since prior treatment(systemic treatment or major surgery)\n* Patient who have recovered from any previous toxicity\n* Man or woman de ≥ 18 years and ≤ 65 years\n* Performance Status (ECOG) ≤ 2 within 7 days before inclusion\n* Polynuclear neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hemoglobin ≥ 9 g/dl\n* Serum Albumin ≥ 36 g/l and lymphocytes ≥ 700/mm3\n* Total bilirubin and SGPT/ALT and SGOT/AST ≤ 3 ULN(≤ 5 ULN if liver metastases)\n* Creatinine in normal ranges and Creatinine clairance \\> 60 ml/min (Cockroft formulae)\n* Central venous access\n* Negative pregnancy test for women who may be pregnant within 7 days before inclusion\n* Effective contraceptive during the treatment period and up to 6 months after the end of treatment (for patients of both sexes during their reproductive and child-bearing age and their partners)\n* Patient covered by government health insurance\n* Informed consent signed by the patient before any specific study procedure\n\nExclusion Criteria:\n\n* Prior treatment by Paclitaxel\n* Oral treatment impossible\n* Known dysphagia, malabsorption or maldigestion\n* Pre-existing neuropathy clinically symptomatic\n* Known leptomeningeal brain metastases\n* Known allergy to Cremophor, to Paclitaxel or one of its excipients (especially polyoxyethylene castor oil), to Cyclophosphamide or one of its excipients (lactose, sucrose)\n* Active and uncontrolled infection\n* Acute urinary tract infection, pre-existing hemorrhagic cystitis\n* Diabetes insipidus\n* History or progressive psychiatric illness\n* Persons under guardianship or detainees\n* Unable for medical follow-up (geographic, social or mental reasons)\n* Pregnant, or likely to be or breastfeeding women\n* Absence of effective contraception for the duration of treatment and 6 months after completion of therapy (for patients of both sexes in childbearing or reproductive age and their partners)'}, 'identificationModule': {'nctId': 'NCT01374620', 'acronym': 'PAL-ANGI2', 'briefTitle': 'Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide', 'orgStudyIdInfo': {'id': 'PAL-ANGI2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel Dose escalation', 'description': 'A standard dose escalation strategy will be used including 3 to 6 patients at each dose level (Paclitaxel dose escalation + fixed dose of cyclophosphamide)\n\n\\+ blood collection', 'interventionNames': ['Drug: Paclitaxel dose escalation', 'Drug: Cyclophosphamide', 'Biological: Blood collection']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort extension', 'description': 'An additional 10 patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose\n\n\\+ blood collection', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Cyclophosphamide', 'Biological: Blood collection']}], 'interventions': [{'name': 'Paclitaxel dose escalation', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'Paclitaxel will be administered intravenously over 60 minutes, at D1, D8 and D15, at a given dose.\n\nThe Paclitaxel dose (mg/infusion) levels are as follows:\n\n* 40\n* 60\n* 70\n* 75\n* 80\n* 85\n* 90', 'armGroupLabels': ['Paclitaxel Dose escalation']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide', 'armGroupLabels': ['Cohort extension']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Endoxan'], 'description': 'D1 to D28: 50 mg x 2/day/cycle\n\n1 cycle = 28 days', 'armGroupLabels': ['Cohort extension', 'Paclitaxel Dose escalation']}, {'name': 'Blood collection', 'type': 'BIOLOGICAL', 'description': 'At D1, D8, D15 and D21 of cycle 1 and cycle 2:2 blood samples for the correlation between clinical response and biological parameters', 'armGroupLabels': ['Cohort extension', 'Paclitaxel Dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Nicolas PENEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}