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

March 16, 2021 updated by: University College, London

A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Dorchester, United Kingdom
        • Dorset County Hospital Nhs Foundation Trust
      • Guildford, United Kingdom
        • Royal Surrey County Hospital
      • Harlow, United Kingdom
        • The Princess Alexandra Hospital NHS Trust
      • Lancaster, United Kingdom
        • University Hospitals of Morecambe Bay NHS Foundation Trust
      • Leicester, United Kingdom
        • University Hospital Leicester NHS Trust
      • London, United Kingdom
        • UCLH
      • London, United Kingdom
        • Guy's and St Thomas' Hospitals NHS Foundation Trust
      • Manchester, United Kingdom
        • The Christie
      • Northwood, United Kingdom
        • East and North Herts NHS Foundation Trust
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust
      • Peterborough, United Kingdom
        • North West Anglia NHS Trust
      • Rhyl, United Kingdom
        • Betsi Cadwaladr University Health Board
      • Steeton, United Kingdom
        • Airedale NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: Defined as the time from randomisation to first progression/death (whichever came first), assessed up to 41 months
Defined as the time from randomisation to first progression/death (whichever came first), assessed up to 41 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomisation to death due to any cause, assessed up to 41 months
From date of randomisation to death due to any cause, assessed up to 41 months
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)
From first tumour assessment to progression/trial end (whichever is first), assessed up to 41 months
Adverse events
Time Frame: From date of consent to 30 days after final trial treatment
Including ophthalmologic and treatment specific toxicities
From date of consent to 30 days after final trial treatment
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
From baseline to progression/trial end (whichever is first), assessed up to 41 months
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
From baseline to progression/trial end (whichever is first), assessed up to 41 months
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
From baseline to progression/trial end (whicenver is first), assessed up to 41 months
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
From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months
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
From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 14, 2017

Primary Completion (ACTUAL)

March 12, 2021

Study Completion (ACTUAL)

March 12, 2021

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (ESTIMATE)

March 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL/12/0515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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