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

• Conditions: Metastatic Lung Cancer; Metastatic Breast Cancer; Metastatic Gastric Cancer; Metastatic Prostate Cancer; Metastatic Bladder Cancer

• Registration Number: NCT01814150
• Lead Sponsor: Gottfried Maya

Brief Summary

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

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.

Study Timeline

• Status Verified: 2013-03
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Last Update Submitted: 2013-03-22
• Last Update Posted: 2013-03-25
• Study Start: 2013-04
• Primary Completion: 2016-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	3 years	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

Secondary Outcome Measures

Name	Time	Method
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	3 years	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

Trial Locations

Locations (1)

Institute of Oncology, Meir Medical Center; 🇮🇱 Kfar-Saba, Israel