Small Cell Lung Cancer
Conditions
Keywords
small cell lung cancer, amrubicin
Brief summary
The purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.
Interventions
DRUGAmrubicin
Amrubicin 45mg/m\<2\> IV days 1, 2 3 of each 21-day cycle until disease progression. Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression.
DRUGCisplatin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus Cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression. Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
DRUGEtoposide
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically/cytologically proven small cell lung cancer * Extensive disease * Measurable disease * World Health Organization (WHO) performance status 0-2 * Age 18 years or older * Normal baseline cardiac function * No prior systemic chemotherapy for small cell lung cancer * Adequate organ function including bone marrow, kidney, and liver * No history of interstitial lung disease or pulmonary fibrosis * No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix * No pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception * Written informed consent before randomization
Exclusion criteria
* Pre-existing peripheral neuropathy (greater than Grade 1, CTCAE version 3.0) * Uncontrolled or severe cardiovascular disease * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks) | Until Disease Progression |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | Until 30 days after last protocol treatment |
| Progression-free survival | Until disease progression or death |
| Overall survival | Until death |
Countries
Belgium, Italy, Netherlands, Poland, United Kingdom
Outcome results
None listed