A Phase 3 interventional study of Carboplatin, etoposide & thalidomide and Carboplatin, etoposide & placebo in Lung Cancer, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-16.
Sponsored by University College, London · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy such as carboplatin and etoposide use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying carboplatin, etoposide, and thalidomide to see how well they work compared to carboplatin and etoposide in treating patients with limited- or extensive-stage small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (limited vs extensive), ECOG performance status (0 and 1 vs 2), and alkaline phosphatase (no greater than 1.5 times upper limit of normal [ULN] vs greater than 1.5 times ULN). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Patients who are unable to receive etoposide IV on day 2 may receive oral etoposide on days 2 and 3.
In both arms, chemotherapy (carboplatin and etoposide) repeats every 3 weeks for up to 6 courses. Patients receive thalidomide or placebo continuously for up to 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may continue to receive thalidomide or placebo provided the patient is clinically and symptomatically stable.
Quality of life is assessed at baseline, during each course of chemotherapy, at 3-4 weeks after completion of chemotherapy, and at 6, 12, 18, and 24 months.
Patients are followed every 2 months for 2 years after the completion of chemotherapy and then every 3 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 372 patients (186 per treatment arm) will be accrued for this study.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 724 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral thalidomide daily beginning on day 1 for up to 24 months.
Drug: Carboplatin, etoposide & thalidomide
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral placebo daily beginning on day 1 for up to 24 months.
Drug: Carboplatin, etoposide & placebo
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral thalidomide daily beginning on day 1 for up to 24 months.
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral placebo daily beginning on day 1 for up to 24 months.
Survival at 2 years after study randomization
Time frame: 0-2 years
Time to disease progression 2 years after study randomization
Time frame: 0-2 years
Toxicity as measured by NCIC CTC 3 times weekly while undergoing chemotherapy, then monthly thereafter
Time frame: Till end of treatment
Response rates as measured by RECIST during each visit while undergoing chemotherapy and after completion of study treatment
Time frame: Till progression
Quality of life as measured by EORTC QLQ-30 and lung-specific questionnaire(LC14) at baseline, after each course, and after completion of study treatment, and at 6, 12, 18, and 24 months after day 1 of course 1
Time frame: 0-24 months
Biological markers (measurement of VEGF, bFGF, TNF alpha, and IL-6)
Time frame: Before treatment courses 1 and 4, and then at 9 and 18 months
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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University College, London