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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01814150
Enrollment
200
Registered
2013-03-19
Start date
2013-04-30
Completion date
2018-04-30
Last updated
2013-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Docetaxel, Alpha 1 Acid Glycoprotein, Outcome

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.

Interventions

None listed

Sponsors

Gottfried Maya
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The association between the baseline plasma level of alpha 1 acid glycoprotein and progression free survival of docetaxel based therapy in patients with metastatic cancer3 yearsThe 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

MeasureTime frameDescription
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 cancer3 yearsThe 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

Countries

Israel

Contacts

Primary ContactDaniel Keizman, MD
danielkeizman@gmail.com97297471408

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026