Plain English Summary
Dr Siow Ming Lee
Meyerstein Institute of Oncology
+44(0)20 7380 9091
Cancer Research UK Ref. C1438/A2932
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.
Not provided at time of registration.
Randomised double blind placebo controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Small cell lung cancer
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.
Cisplatin and Etoposide (PE Chemotherapy) and thalidomide.
Primary outcome measure
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
Overall trial end date
Reason abandoned (if study stopped)
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, partners 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
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
Cancer Research UK (CRUK) (UK) (ref. C1438/A2932)
Funding Body Type
private sector organisation
Funding Body Subtype
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
Basic results (scientific)
2009 results in http://www.ncbi.nlm.nih.gov/sites/pubmed/19608997