This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive relationship between mRNA BRCAI levels and the response to different chemotherapy combinations plus Avastin. A subset of patients participating in MO19390, and receiving Avastin 15mg/kg iv on day 1 and subsequently once every 3 weeks, will undergo BRCAI mRNA expression determination. Depending on the BRCAI mRNA level (low, medium or high) they will receive a different chemotherapy regimen in combination with Avastin: a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.
15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks
Unnamed facility
Alcorcón, Spain
Unnamed facility
Alcoy, Spain
Unnamed facility
Alicante, Spain
Unnamed facility
Badalona, Spain
Unnamed facility
Barakaldo, Spain
Unnamed facility
Burgos, Spain
Unnamed facility
Elche, Spain
Unnamed facility
Girona, Spain
Unnamed facility
Huesca, Spain
Unnamed facility
Las Palmas de Gran Canaria, Spain
...and 12 more locations
Progression-free survival
Time frame: Event driven
Overall survival; response rates
Time frame: Event driven
Adverse events
Time frame: Throughout study
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