NCT00969306

Brief Summary

Chloroquine might very well be able to increase overall survival in small cell lung cancer by sensitizing cells resistant to chemotherapy and radiotherapy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2013

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
4 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

August 31, 2009

Last Update Submit

February 12, 2019

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the toxicity of adding chloroquine in escalating doses in SCLC patients: to standard dose cisplatin-etoposide in extensive disease SCLC; to standard dose concurrent radiotherapy and cisplatin-etoposide in limited disease SCLC

    6 years

Secondary Outcomes (2)

  • Tumor response (according to RECIST)

    6 years

  • Overall survival

    6 years

Study Arms (1)

Chloroquine

ACTIVE COMPARATOR

Patients receive Chloroquine

Drug: Chloroquine, A-CQ 100

Interventions

Chloroquine, A-CQ 100DRUG

Administration: * Orally * Timing: Once daily * Tablets of 100 mg * During or after meals * In case of missed dose: intake of the missed dose is still possible up until 12 hours before the next dose. * Patients should always note date and time of intake on the chloroquine monitoring form.

Chloroquine

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed ''extensive disease'' (Stage T0-4 N0-3 M1) small cell lung cancer
  • At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan.
  • WHO performance status 0-2
  • Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
  • Calculated creatinine clearance at least 60 ml/min
  • Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
  • No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
  • Life expectancy more than 6 months
  • Willing and able to comply with the study prescriptions
  • years or older
  • Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
  • Ability to give and having given written informed consent before patient registration
  • No mixed pathology, e.g. non-small cell plus small cell cancer
  • No recent (\< 3 months) severe cardiac disease (NYHA class \>1) (congestive heart failure, infarction)
  • No history of cardiac arrythmia (multifocal premature ventricular contractions, uncontrolled atrial fibrillation, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic and requiring treatment (CTC AE 4.0), or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.
  • +12 more criteria

You may not qualify if:

  • The opposite of the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

NKI/AvL

Amsterdam, Netherlands

Location

VU Medical Center

Amsterdam, Netherlands

Location

Maastricht Radiation Oncology

Maastricht, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Philippe Lambin, DM, PhD

    Maastricht Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

September 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

NL(4)