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STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)

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ClinicalTrials.gov Identifier: NCT02722369
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Gemcitabine Drug: Carboplatin Drug: Etoposide Drug: Hydroxychloroquine Phase 2

Detailed Description:

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.

The 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.

Patients are randomised to one of two treatment arms; carboplatin/etoposide or gemcitabine/carboplatin/hydroxychloroquine.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Active Comparator: Control Arm
  • IV carboplatin AUC5 (area under curve) on Day1
  • IV etoposide 120mg/m2 Day 1, followed by oral etoposide 100mg BD (twice daily) on Day 2 and Day 3
Drug: Carboplatin
Chemotherapy

Drug: Etoposide
Chemotherapy

Experimental: Investigational Arm
  • IV gemcitabine 1200mg/m2 on Day 1 and Day 8
  • IV carboplatin AUC5 on Day 1
  • Oral HCQ will be taken at a dose of 400mg BD from day 1 of cycle 1 (maximum of 30 months)
Drug: Gemcitabine
Chemotherapy

Drug: Carboplatin
Chemotherapy

Drug: Hydroxychloroquine
Maintenance Agent




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Defined as the time from randomisation to first progression/death (whichever came first), assessed up to 41 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From date of randomisation to death due to any cause, assessed up to 41 months ]
  2. Objective response as measured by Response Evaluation Criteria in Solid Tumours (RECIST) v.1.1 [ Time Frame: From first tumour assessment to progression/trial end (whichever is first), assessed up to 41 months ]
    Complete Response (CR)/ Partial Response (PR)/ Progressive Disease (PD)/ Stable Disease (SD)

  3. Adverse events [ Time Frame: From date of consent to 30 days after final trial treatment ]
    Including ophthalmologic and treatment specific toxicities

  4. Quality of life as measured by EQ-5D [ Time Frame: From baseline to progression/trial end (whichever is first), assessed up to 41 months ]
    The questionnaire is a standardised questionnaire

  5. Quality of life as measured by QLQC-30 [ Time Frame: From baseline to progression/trial end (whichever is first), assessed up to 41 months ]
    The questionnaire is a standardised questionnaire

  6. Quality of life as measured by QLQ-LC-13 [ Time Frame: From baseline to progression/trial end (whicenver is first), assessed up to 41 months ]
    The questionnaire is a standardised questionnaire

  7. Compliance measured by dose intensity [ Time Frame: From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months ]
    Capturing dose delays, modifications and omissions

  8. Compliance measured by dose exposure [ Time Frame: From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months ]
    Capturing dose delays, modifications and omissions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed SCLC
  • Stage IV disease
  • Performance status ECOG 0-2
  • Life expectancy >8 weeks
  • Age 18 or over
  • Willing and able to give informed consent
  • Patient considered able to tolerate chemotherapy
  • Adequate renal function - defined by GFR ≥50mL/min as measured by EDTA or C&G
  • Adequate bone marrow reserve: Absolute neutrophil count ≥1.5 x 109/L, haemoglobin ≥90 g/L, platelet count ≥100 x 109/L
  • Negative pregnancy test for WCBP
  • Highly effective contraception is mandatory for all patients of reproductive potential
  • At least one site of measurable disease (target lesion) for RECIST 1.1 evaluation
  • Hypersensitivity or history of severe allergic reaction to any of the IMPs
  • Able to swallow medication

Exclusion Criteria:

  • Mixed cell histology (i.e. NSCLC and SCLC)
  • Prior macular degeneration or diabetic retinopathy
  • History of glaucoma
  • Patients with abnormal LFTs (ALP, ALT/AST*) that are ≥3 x ULN (≥5 x ULN for patients with liver metastases)
  • Patients with abnormal bilirubin levels that are ≥1.5 x ULN
  • Prior treatment for this disease e.g. chemotherapy, surgery, radiotherapy (except palliative radiotherapy to bone metastases)
  • Documented side effects to chloroquine or related agents
  • Treatment with chloroquine or related agents within the last year prior to randomisation
  • 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
  • Previous medical history of prolonged QT interval
  • 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
  • Patients with symptomatic brain metastases
  • Women who are breastfeeding
  • Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs e.g. phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine
  • Patients who are unable to have their digoxin levels regularly monitored

    • if both ALT and AST performed then both need to be recorded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722369


Contacts
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Contact: Richard Jenner 02076799521 ctc.study15@ucl.ac.uk
Contact: Yen Ngai ctc.study15@ucl.ac.uk

Locations
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United Kingdom
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom
Contact: Madeleine Hewish         
The Princess Alexandra Hospital NHS Trust Recruiting
Harlow, United Kingdom
Contact: Dionysis Papadatos-Pastos         
UCLH Recruiting
London, United Kingdom
Contact: Siow-Ming Lee         
The Christie Recruiting
Manchester, United Kingdom
Contact: Fiona Blackhall         
Peterborough and Stamford Recruiting
Peterborough, United Kingdom
Contact: Abigail Hollingdale         
Airedale NHS Foundation Trust Recruiting
Steeton, United Kingdom
Contact: Dan Lee         
Sponsors and Collaborators
University College, London

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02722369     History of Changes
Other Study ID Numbers: UCL/12/0515
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Hydroxychloroquine
Carboplatin
Etoposide
Etoposide phosphate
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antimalarials
Antiprotozoal Agents