ISRCTN77341241CompletedPhase 2
A phase II/III randomised, double blind, placebo controlled trial of gemcitabine/carboplatin with or without thalidomide in advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor not defined - Record supplied by London Lung Cancer Group0 sites722 target enrollmentStarted: July 2, 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 722
Study Overview
Brief Summary
2009 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19770378 results
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
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
Investigators
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