Clinical trial NCT01814150: The Association Between Alpha 1 Acid Glycoprotein Level and Outcome Metastatic Cancer Treated With Docetaxel
Official title: The Association Between Alpha 1 Acid Glycoprotein Level and Outcome of Patients With Metastatic Cancer Treated With Docetaxel Based Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Lung Cancer
Metastatic Breast Cancer
Metastatic Gastric Cancer
Metastatic Prostate Cancer
Metastatic Bladder Cancer
Keywords: Docetaxel
Alpha 1 Acid Glycoprotein
Outcome
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Metastatic cancer from lung, breast, gastric, prostate, and bladder origin, treated with docetaxel based chemotherapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: 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
timeFrame: 3 years
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Institute of Oncology, Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Daniel Keizman, MD
role: PRINCIPAL_INVESTIGATOR
References: