A phase III randomised, double blind, placebo controlled trial of carboplatin/etoposide with or without thalidomide in small cell lung cancer
| ISRCTN | ISRCTN16174527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16174527 |
| ClinicalTrials.gov (NCT) | NCT00061919 |
| Protocol serial number | Cancer Research UK Ref. C1438/A2932 |
| Sponsor | Sponsor not defined - Record supplied by London Lung Cancer Group |
| Funder | Cancer Research UK (CRUK) (UK) (ref. C1438/A2932) |
- Submission date
- 02/07/2003
- Registration date
- 02/07/2003
- Last edited
- 29/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Siow Ming Lee
Scientific
Scientific
Middlesex/UCL Hospitals
Meyerstein Institute of Oncology
Mortimer Street
London
W1T 3AA
United Kingdom
| Phone | +44(0)20 7380 9091 |
|---|---|
| sm.lee@uclh.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A phase III randomised, double blind, placebo controlled trial of carboplatin/etoposide with or without thalidomide in small cell lung cancer |
| Study acronym | Study 12 |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Cisplatin and Etoposide (PE Chemotherapy) and thalidomide. |
| Primary outcome measure(s) |
To determine if survival is affected by the addition of thalidomide in patients with SCLC treated with carboplatin/ etoposide. |
| Key secondary outcome measure(s) |
To determine the effects of thalidomide on: time to disease progression, toxicity, response rate, quality of life and, in selected centres, biological markers. |
| Completion date | 07/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | |
| Target sample size at registration | 372 |
| Total final enrolment | 724 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 07/11/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Middlesex/UCL Hospitals
London
W1T 3AA
United Kingdom
W1T 3AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/08/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 09/07/2010 | 29/10/2021 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
