Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-05 @ 5:31 PM
Study NCT ID:
NCT02722369
Status:
TERMINATED
Last Update Posted:
2021-03-18
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'whyStopped': 'Low recruitment, lack of efficacy and increased adverse events in investigational arm.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'Defined as the time from randomisation to first progression/death (whichever came first), assessed up to 41 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of randomisation to death due to any cause, assessed up to 41 months'}, {'measure': 'Objective response as measured by Response Evaluation Criteria in Solid Tumours (RECIST) v.1.1', 'timeFrame': 'From first tumour assessment to progression/trial end (whichever is first), assessed up to 41 months', 'description': 'Complete Response (CR)/ Partial Response (PR)/ Progressive Disease (PD)/ Stable Disease (SD)'}, {'measure': 'Adverse events', 'timeFrame': 'From date of consent to 30 days after final trial treatment', 'description': 'Including ophthalmologic and treatment specific toxicities'}, {'measure': 'Quality of life as measured by EQ-5D', 'timeFrame': 'From baseline to progression/trial end (whichever is first), assessed up to 41 months', 'description': 'The questionnaire is a standardised questionnaire'}, {'measure': 'Quality of life as measured by QLQC-30', 'timeFrame': 'From baseline to progression/trial end (whichever is first), assessed up to 41 months', 'description': 'The questionnaire is a standardised questionnaire'}, {'measure': 'Quality of life as measured by QLQ-LC-13', 'timeFrame': 'From baseline to progression/trial end (whicenver is first), assessed up to 41 months', 'description': 'The questionnaire is a standardised questionnaire'}, {'measure': 'Compliance measured by dose intensity', 'timeFrame': 'From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months', 'description': 'Capturing dose delays, modifications and omissions'}, {'measure': 'Compliance measured by dose exposure', 'timeFrame': 'From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months', 'description': 'Capturing dose delays, modifications and omissions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine (HCQ) is associated with an improved clinical outcome (progression free and overall survival) compared with chemotherapy alone in patients with small cell lung cancer (SCLC)', 'detailedDescription': 'This is a multicentre, randomised, phase II trial which aims to compare the combination of hydroxychloroquine and gemcitabine/carboplatin versus standard carboplatin/etoposide chemotherapy, as first line treat in patients with stage IV disease.\n\nThe standard first line chemotherapy treatment remains a platinum-based chemotherapy and this has been unchanged for 20 years. Novel active treatment approaches are urgently needed to improve survival in SCLC.\n\nPatients are randomised to one of two treatment arms; carboplatin/etoposide or gemcitabine/carboplatin/hydroxychloroquine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed SCLC\n* Stage IV disease\n* Performance status ECOG 0-2\n* Life expectancy \\>8 weeks\n* Age 18 or over\n* Willing and able to give informed consent\n* Patient considered able to tolerate chemotherapy\n* Adequate renal function - defined by GFR ≥50mL/min as measured by EDTA or C\\&G\n* Adequate bone marrow reserve: Absolute neutrophil count ≥1.5 x 109/L, haemoglobin ≥90 g/L, platelet count ≥100 x 109/L\n* Negative pregnancy test for WCBP\n* Highly effective contraception is mandatory for all patients of reproductive potential\n* At least one site of measurable disease (target lesion) for RECIST 1.1 evaluation\n* Hypersensitivity or history of severe allergic reaction to any of the IMPs\n* Able to swallow medication\n\nExclusion Criteria:\n\n* Mixed cell histology (i.e. NSCLC and SCLC)\n* Prior macular degeneration or diabetic retinopathy\n* History of glaucoma\n* Patients with abnormal LFTs (ALP, ALT/AST\\*) that are ≥3 x ULN (≥5 x ULN for patients with liver metastases)\n* Patients with abnormal bilirubin levels that are ≥1.5 x ULN\n* Prior treatment for this disease e.g. chemotherapy, surgery, radiotherapy (except palliative radiotherapy to bone metastases)\n* Documented side effects to chloroquine or related agents\n* Treatment with chloroquine or related agents within the last year prior to randomisation\n* Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial\n* Previous medical history of prolonged QT interval\n* A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer\n* Patients with symptomatic brain metastases\n* Women who are breastfeeding\n* Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs e.g. phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine\n* Patients who are unable to have their digoxin levels regularly monitored\n\n * if both ALT and AST performed then both need to be recorded'}, 'identificationModule': {'nctId': 'NCT02722369', 'briefTitle': 'STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)', 'orgStudyIdInfo': {'id': 'UCL/12/0515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': '* IV carboplatin AUC5 (area under curve) on Day1\n* IV etoposide 120mg/m2 Day 1, followed by oral etoposide 100mg BD (twice daily) on Day 2 and Day 3', 'interventionNames': ['Drug: Carboplatin', 'Drug: Etoposide']}, {'type': 'EXPERIMENTAL', 'label': 'Investigational Arm', 'description': '* IV gemcitabine 1200mg/m2 on Day 1 and Day 8\n* IV carboplatin AUC5 on Day 1\n* Oral HCQ will be taken at a dose of 400mg BD from day 1 of cycle 1 (maximum of 30 months)', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Carboplatin', 'Drug: Hydroxychloroquine']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Investigational Arm']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Control Arm', 'Investigational Arm']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Control Arm']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Maintenance Agent', 'armGroupLabels': ['Investigational Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dorchester', 'country': 'United Kingdom', 'facility': 'Dorset County Hospital NHS Foundation Trust', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}, {'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'city': 'Harlow', 'country': 'United Kingdom', 'facility': 'The Princess Alexandra Hospital NHS Trust', 'geoPoint': {'lat': 51.77655, 'lon': 0.11158}}, {'city': 'Lancaster', 'country': 'United Kingdom', 'facility': 'University Hospitals of Morecambe Bay NHS Foundation Trust', 'geoPoint': {'lat': 54.04649, 'lon': -2.79988}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospital Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'UCLH', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Northwood', 'country': 'United Kingdom', 'facility': 'East and North Herts NHS Foundation Trust', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Peterborough', 'country': 'United Kingdom', 'facility': 'North West Anglia NHS Trust', 'geoPoint': {'lat': 52.57364, 'lon': -0.24777}}, {'city': 'Rhyl', 'country': 'United Kingdom', 'facility': 'Betsi Cadwaladr University Health Board', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}, {'city': 'Steeton', 'country': 'United Kingdom', 'facility': 'Airedale NHS Foundation Trust', 'geoPoint': {'lat': 53.88333, 'lon': -1.95}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'On receipt of a request the recipient will consider the proposal, ensure relevant Chief Investigator/Trial Management Group are consulted and, if necessary, Trial Steering Committee and/or Cancer Trials Centre (CTC) Senior Management Group. Any shared data will be in an anonymised format'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}