Condition category
Cancer
Date applied
02/07/2003
Date assigned
02/07/2003
Last edited
24/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Siow Ming Lee

ORCID ID

Contact details

Middlesex/UCL Hospitals
Meyerstein
Institute of Oncology
Mortimer Street
London
W1T 3AA
United Kingdom
+44 (0)20 7380 9091
sm.lee@uclh.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

LLCG Study 14

Study hypothesis

Primary objective:
To determine if survival is affected by the addition of thalidomide in patients with Non-Small Cell Lung Cancer (NSCLC) treated with gemcitabine/carboplatin.

Secondary objective:
To determine the effects of thalidomide on:
1. Time to disease progression
2. Toxicity
3. Response rate
4. Quality of life

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Non-small cell lung cancer

Intervention

Patients on the trial will receive up to 4 cycles of gemcitabine and carboplatin at 3 weekly intervals. Patients will be randomised to receive either thalidomide or placebo daily beginning on day 1 for up to 24 months.

Intervention type

Drug

Phase

Phase II/III

Drug names

Gemcitabine, carboplatin, thalidomide

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

07/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically confirmed NSCLC, stage IIIb or IV
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 and estimated life expectancy of at least 8 weeks
3. Adequate renal function and bone marrow reserve
4. Women Of Childbearing Potential (WCBP) must agree to practice complete abstinence from heterosexual intercourse or to use TWO methods of contraception while on study medication, and have a negative serum or urine pregnancy test within the 24 hours before starting study medication. Those who are sexually active in a heterosexual relationship must agree to have pregnancy tests every 4 weeks while on study medication and 4 weeks after the last dose of study medication
5. Male patients (including those who have had a vasectomy) must use barrier contraception when engaging in heterosexual activity with WCBP while on study medication and 4 weeks after the last dose

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

514

Participant exclusion criteria

1. Pregnant or lactating women or WCBP not using adequate contraception
2. Prior treatment with chemotherapy or radiotherapy
3. 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
4. Prior history of thromboembolic event (including: Pulmonary Embolism [PE], Deep Vein Thrombus [DVT], Cerebro-Vascular Accident [CVA]/Transient Ischaemic Attack [TIA])
5. Symptomatic brain metastases thought to require immediate radiotherapy
6. 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

Recruitment start date

01/01/2003

Recruitment end date

07/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Middlesex/UCL Hospitals
London
W1T 3AA
United Kingdom

Sponsor information

Organisation

Sponsor not defined - Record supplied by London Lung Cancer Group

Sponsor details

-
London
-
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

London Lung Cancer Group (UK) (Charity no. 1074994) - LLCG study 14

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19770378

Publication citations

  1. Results

    Lee SM, Rudd R, Woll PJ, Ottensmeier C, Gilligan D, Price A, Spiro S, Gower N, Jitlal M, Hackshaw A, Randomized double-blind placebo-controlled trial of thalidomide in combination with gemcitabine and Carboplatin in advanced non-small-cell lung cancer., J. Clin. Oncol., 2009, 27, 31, 5248-5254, doi: 10.1200/JCO.2009.21.9733.

Additional files

Editorial Notes