Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-18 @ 7:05 PM
Study NCT ID:
NCT00097851
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2004-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)
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': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C120158', 'term': 'phosphomannopentaose sulfate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2004-11-30', 'studyFirstSubmitQcDate': '2004-11-30', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival'}], 'secondaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Response rate'}, {'measure': 'Quality of life'}, {'measure': 'Overall survival'}]}, 'conditionsModule': {'keywords': ['second-line', 'combination', 'chemotherapy', 'anti-angiogenic'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': "PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients with non-small-cell lung cancer who haven't responded to first-line therapies (platinum-based drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months after starting docetaxel treatment. The PR88202 study has been designed to compare two different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which is more effective against the cancer. It is hoped that the combination of PI-88 with docetaxel will allow patients to extend the time it takes for their disease to progress, and also to improve their quality of life.", 'detailedDescription': 'PR88202 is an open-label randomized study. In the initial phase of the study, patients will be randomized to receive weekly docetaxel alone, or PI-88 in combination with weekly docetaxel. Both groups will receive docetaxel (30 mg/m2), administered by intravenous infusion on days 1, 8 and 15 of a 28-day cycle. The second group only will receive PI-88 (250 mg/day) in addition to docetaxel; PI-88 will be administered by subcutaneous injection on days 1-4, 8-11 and 15-18 of each cycle. The primary efficacy endpoint is the non-progression rate at 6 months. In the extension phase of the study, patients in the combination arm who have stable disease or an objective response after up to six treatment cycles will remain on PI-88 alone as maintenance therapy. Patients who initially receive docetaxel alone and who have disease progression or unacceptable toxicity before the completion of six cycles will be eligible to receive PI-88 alone as third-line therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically or cytologically confirmed stage IIIb or IV NSCLC that has progressed during or after first-line treatment\n* measurable disease by spiral CT chest scan, as defined in RECIST criteria\n* performance status 0-1 (ECOG)\n* life expectancy at least 2 months\n* adequate hemopoietic, renal and hepatic function\n\nExclusion Criteria:\n\n* current symptomatic central nervous system (CNS) involvement\n* prior or co-existent malignancies\n* significant non-malignant disease\n* acute or chronic gastrointestinal (GI) bleeding in last two years\n* inflammatory bowel disease\n* abnormal bleeding tendency\n* patients at risk of bleeding due to open wounds or planned surgery\n* clinically significant hemoptysis within the past 4 weeks\n* bilirubin \\> upper limit of normal (ULN)\n* ALT and AST \\> 2.5 times ULN, or \\> 1.5 times ULN if alkaline phosphatase \\> 2.5 times ULN\n* alkaline phosphatase \\> 5 times ULN, unless patient has bone metastases\n* myocardial infarction, stroke or congestive heart failure within last 3 months\n* prior treatment with docetaxel\n* concomitant treatment with aspirin (\\>100 mg/day), NSAIDs (except selective COX-2 inhibitors, warfarin (\\>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4 inhibitors\n* women who are pregnant or breast-feeding\n* women of child-bearing potential not using adequate contraception\n* history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin\n* history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease\n* allergy to polysorbate 80 (component of Taxotere®)\n* uncontrolled or serious infection in last 4 weeks'}, 'identificationModule': {'nctId': 'NCT00097851', 'briefTitle': 'Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellxpert Biotechnology Corp.'}, 'officialTitle': 'Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'PR88202'}}, 'armsInterventionsModule': {'interventions': [{'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'PI-88', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Cancer Centre, Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2077', 'city': 'Hornsby', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Haematology and Oncology Clinics', 'geoPoint': {'lat': -33.70244, 'lon': 151.09931}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '2298', 'city': 'Waratah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Newcastle Mater Misericordiae Hospital', 'geoPoint': {'lat': -32.90667, 'lon': 151.72647}}, {'zip': '4032', 'city': 'Chermside', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Prince Charles Hospital', 'geoPoint': {'lat': -27.38472, 'lon': 153.03062}}, {'zip': '4560', 'city': 'Nambour', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Nambour General Hospital', 'geoPoint': {'lat': -26.62613, 'lon': 152.95941}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Mater Hospital', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '5011', 'city': 'Woodville', 'state': 'South Australia', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.877, 'lon': 138.54291}}, {'zip': '3187', 'city': 'Prahran', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.85114, 'lon': 144.99318}}, {'zip': '3690', 'city': 'Wodonga', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Border Medical Oncology', 'geoPoint': {'lat': -36.12179, 'lon': 146.88809}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'overallOfficials': [{'name': 'Nick Pavlakis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal North Shore Hospital'}, {'name': 'Paul Mitchell, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Austin and Repatriation Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellxpert Biotechnology Corp.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medigen Biotechnology Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}