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

NCT00061919

Protocol/serial number

Cancer Research UK Ref. C1438/A2932

Study information

Scientific title

Acronym

Study 12

Study hypothesis

Since tumour growth and metastasis are angiogenesis dependent, therapeutic strategies aimed at inhibiting angiogenesis are theoretically attractive. Thalidomide has anti-angiogenic and anti-cachexic effects which may complement the anti-tumour effect obtained from chemotherapy. Preliminary data from a recently completed phase II trial in SCLC appeared to show promising clinical activity when thalidomide was added to chemotherapy and as maintenance therapy. The combination was well tolerated without adding to the expected toxicities of the chemotherapy.

Ethics approval

Not provided at time of registration.

Study design

Randomised double blind placebo controlled 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

Small cell lung cancer

Intervention

Patients on both arms will receive carboplatin on day one and etoposide on day one, two and three on a three weekly regimen (six cycles).

All patients will be randomised to receive either thalidomide or placebo daily beginning on day one for up to 24 months.

Intervention type

Drug

Phase

Phase III

Drug names

Cisplatin and Etoposide (PE Chemotherapy) and thalidomide.

Primary outcome measures

To determine if survival is affected by the addition of thalidomide in patients with SCLC treated with carboplatin/ etoposide.

Secondary outcome measures

To determine the effects of thalidomide on: time to disease progression, toxicity, response rate, quality of life and, in selected centres, biological markers.

Overall trial start date

01/04/2003

Overall trial end date

07/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically confirmed small cell lung cancer
2. Limited or extensive stage disease
3. Have had no prior chemotherapy or radiotherapy
4. Have no symptomatic brain metastases thought to require immediate radiotherapy
5. No 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
6. Either sex, age over 18
7. Eastern Cooperative Oncology Group (ECOG) performance status zero to three
8. Estimated life expectancy of at least eight weeks
9. Renal function adequate for chemotherapy i.e. Ethylene Diamine Tetraacetic Acid (EDTA) clearance greater than 60 ml/min
10. Women of Child-Bearing Potential (WCBP) MUST have a negative serum or urine pregnancy test (minimal sensitivity 50 mIU/mL) performed by healthcare professional within 24 hours before starting study medication
11. WCBP must agree to practice complete abstinence from heterosexual intercourse or to use two methods of contraception (must include one highly effective barrier method [i.e. intrauterine device, hormonal birth control pills, injections or implants, tubal litigation, partner’s vasectomy) and one additional effective barrier method (i.e. latex or polyurethane condom, diaphragm, cervical cap) while on study medication and for four weeks after the last dose of study medication
12. WCBP who are sexually active in a heterosexual relationship must agree to have pregnancy tests every four weeks while on study medication and four weeks after the last dose of study medication
13. Male patients (including those who have had a vasectomy) must use barrier contraception (latex or polyurethane condoms) when engaging in heterosexual activity with WCBP while on study medication and four weeks after the last dose of study medication
14. Pregnant or lactating women or WCBP not using adequate contraception are excluded.
15. All WCBP who have had unprotected sexual intercourse within two weeks prior to study entry should not start study until the beginning of her next period or a negative pregnancy test
16. No history of prior malignant tumour, unless patient has been without evidence of disease for at least three years or the tumour was a non-melanoma tumour or early cervical cancer

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

372

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 three years or the tumour was a non-melanoma skin tumour or early cervical cancer

Recruitment start date

01/04/2003

Recruitment end date

07/11/2005

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

N/A
London
N/A
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref. C1438/A2932)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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/sites/pubmed/19608997

Publication citations

Additional files

Editorial Notes