NCT01814150

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 25, 2013

Status Verified

March 1, 2013

Enrollment Period

3 years

First QC Date

March 5, 2013

Last Update Submit

March 22, 2013

Conditions

Keywords

DocetaxelAlpha 1 Acid GlycoproteinOutcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Oncology Institute, Meir Medical Center

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology, Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Lung NeoplasmsBreast NeoplasmsStomach NeoplasmsProstatic NeoplasmsUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder DiseasesUrologic Diseases

Study Officials

  • Daniel Keizman, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Keizman, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Institution of Oncology

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 19, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2018

Last Updated

March 25, 2013

Record last verified: 2013-03

Locations