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

March 22, 2013 updated by: Gottfried Maya

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Kfar-Saba, Israel
        • Institute of Oncology, Meir Medical Center
        • Principal Investigator:
          • Daniel Keizman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Metastatic cancer from lung, breast, gastric, prostate, and bladder origin, treated with docetaxel based chemotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Oncology Institute, Meir Medical Center
Metastatic cancer patients treated with docetaxel at the Oncology Institute, Meir Medical Center

What is the study measuring?

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
Time Frame: 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
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
Time Frame: 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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gottfried Maya

Investigators

  • Principal Investigator: Daniel Keizman, MD, Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

April 1, 2016

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (ESTIMATE)

March 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 22, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1AGP1234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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