The Association Between Alpha 1 Acid Glycoprotein Level and Outcome Metastatic Cancer Treated With Docetaxel

Study Overview
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Brief Summary
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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.

Detailed Description
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Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including non small cell 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 non small cell lung cancer patients. The investigators aim to prospectively study the association between the baseline plasma level of alpha 1 acid glycoprotein (measured on the first day of the first cycle of docetaxel) and the outcome (response rete, progression free survival, overall survival) of docetaxel based therapy in patients with metastatic non small cell lung cancer, breast cancer, stomach cancer, prostate cancer, and bladder cancer.

Official Title
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The Association Between Alpha 1 Acid Glycoprotein Level and Outcome of Patients With Metastatic Cancer Treated With Docetaxel Based Chemotherapy

Conditions
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Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Gastric Cancer, Metastatic Prostate Cancer, Metastatic Bladder Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oncology Institute, Meir Medical Center<br>Metastatic cancer patients treated with docetaxel at the Oncology Institute, Meir Medical Center | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Docetaxel, Alpha 1 Acid Glycoprotein, Outcome