Metastatic Breast Cancer Clinical Trial
Official title:
The Association Between Alpha 1 Acid Glycoprotein Level and Outcome of Patients With Metastatic Cancer Treated With Docetaxel Based Chemotherapy
Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including
lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer.
One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein.
Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated
with the outcome of docetaxel based therapy in cancer patients.
The investigators aim to prospectively study the association between the plasma level of
alpha 1 acid glycoprotein and the outcome of docetaxel based therapy in cancer patients.
| Status | Not yet recruiting |
| Enrollment | 200 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria - patients with metastatic cancer from lung, breast, gastric, prostate, and bladder origin - patients must be treated with docetaxel based chemotherapy - patients must sign an informed consent form Exclusion Criteria - patients with metastatic cancer other than lung, breast, gastric, prostate, and bladder origin - patients treated with chemotherapy other than docetaxel - patients that did not sign an informed consent form |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Institute of Oncology, Meir Medical Center | Kfar-Saba |
| Lead Sponsor | Collaborator |
|---|---|
| Gottfried Maya |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The association between the baseline plasma level of alpha 1 acid glycoprotein and progression free survival of docetaxel based therapy in patients with metastatic cancer | The association between the baseline plasma level of alpha 1 acid glycoprotein and progression free survival of docetaxel based therapy in patients with metastatic non small cell lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer | 3 years | No |
| Secondary | The association between the baseline plasma level of alpha 1 acid glycoprotein and the response rate and overall survival of docetaxel based therapy in patients with metastatic cancer | The association between the baseline plasma level of alpha 1 acid glycoprotein and the response rate and overall survival of docetaxel based therapy in patients with metastatic non small cell lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer | 3 years | No |
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