Not provided
Not provided
Not provided
Not provided
Not provided
Terminated due to low enrollment. No statistical analyses were performed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard chemotherapy | Drug | As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Event driven |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival; response rates | Event driven | |
| Adverse events | Throughout study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcorcón | 28922 | Spain | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| bevacizumab [Avastin] | Drug | 15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks |
|
| Alcoy |
| 03804 |
| Spain |
| Alicante | 03010 | Spain |
| Badalona | 08915 | Spain |
| Barakaldo | 48903 | Spain |
| Burgos | 09005 | Spain |
| Elche | 03203 | Spain |
| Girona | 17007 | Spain |
| Huesca | 22004 | Spain |
| Las Palmas de Gran Canaria | 35016 | Spain |
| Lugo | 27004 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28040 | Spain |
| Madrid | 28046 | Spain |
| Murcia | 30008 | Spain |
| Palma de Mallorca | 07014 | Spain |
| Pamplona | 31008 | Spain |
| Salamanca | 37007 | Spain |
| San Cristóbal de La Laguna | 38320 | Spain |
| Valencia | 41014 | Spain |
| Valencia | 46009 | Spain |
| Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided