A phase III randomised, double blind, placebo controlled trial of carboplatin/etoposide with or without thalidomide in small cell lung cancer
- Conditions
- Small cell lung cancerCancerMalignant neoplasm of bronchus or lung
- Registration Number
- ISRCTN16174527
- Lead Sponsor
- Sponsor not defined - Record supplied by London Lung Cancer Group
- Brief Summary
2009 Results article in http://www.ncbi.nlm.nih.gov/sites/pubmed/19608997 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 724
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if survival is affected by the addition of thalidomide in patients with SCLC treated with carboplatin/ etoposide.
- Secondary Outcome Measures
Name Time Method To determine the effects of thalidomide on: time to disease progression, toxicity, response rate, quality of life and, in selected centres, biological markers.