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Biomarkers of Response to Taxotere in HRPC. ICORG 08-08, V2

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ClinicalTrials.gov Identifier: NCT01160705
Recruitment Status : Active, not recruiting
First Posted : July 12, 2010
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Tracking Information
First Submitted Date July 9, 2010
First Posted Date July 12, 2010
Last Update Posted Date May 24, 2017
Study Start Date November 2009
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2012)
Presence of mRNA in circulating tumor cells as a predictor of response [ Time Frame: ongoing ]
Original Primary Outcome Measures
 (submitted: July 9, 2010)
Presence of mRNA in circulating tumor cells as a predictor of response
Change History Complete list of historical versions of study NCT01160705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 24, 2012)
Development of a predictive model [ Time Frame: End of trial ]
Original Secondary Outcome Measures
 (submitted: July 9, 2010)
Development of a predictive model
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers of Response to Taxotere in HRPC. ICORG 08-08, V2
Official Title Biomarkers of Response to Taxotere in Hormone-Refractory Prostate Cancer
Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying blood samples in predicting how patients with prostate cancer will respond to treatment with docetaxel.

Detailed Description

OBJECTIVES:

Primary

  • To determine if mRNA present in circulating tumor cells will help predict response in patients with hormone-refractory prostate cancer treated with docetaxel.
  • In parallel with this, based on discoveries made since our protocol was initially submitted to ICORG, here we also propose to analyse serum specimens from these consenting patients for the presence of EC miRNA, mRNA and protein predictive of response to Taxotere.

Secondary

  • To develop a predictive model based on the most accurate and sensitive combination of these biomarkers.

OUTLINE: This is a multicenter study.

Treatment Plan:

All patients will be treated with Docetaxel on a weekly, biweekly or three weekly schedule, dose and schedule at the discretion of the treating physician.

Blood samples are collected for biomarker laboratory studies at baseline, every 3-4 weeks during study, and at disease progression or every 12 weeks after completion of study. Samples are analyzed for mRNA via RT-PCR.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hormone refractory Prostate Cancer patients who are due to receive their first treatment with Docetaxel.
Condition
  • Metastatic Cancer
  • Prostate Cancer
Intervention
  • Drug: docetaxel
  • Genetic: RNA analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: circulating tumor cell analysis
  • Other: laboratory biomarker analysis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 4, 2016)
43
Original Estimated Enrollment
 (submitted: July 9, 2010)
50
Study Completion Date Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients must satisfy the following criteria:

  1. Patients must, in the opinion of the Investigator, be suitable for treatment with Docetaxel on a weekly, biweekly or three weekly schedule.
  2. Patients must be aged 18 years or over.
  3. Patients must have histologically or cytologically proven adenocarcinoma of the prostate gland.
  4. Patients must have evidence of locally advanced or metastatic disease (e.g. bone, pelvic mass, lymph node, liver or lung metastases).
  5. Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (LHRH-agonist etc.) with evidence of treatment failure.
  6. Patients must not have received prior treatment with chemotherapy.
  7. Patients must be able to give written informed consent.
  8. Prior radiotherapy is allowed.
  9. Concomitant use of bisphosphonates is allowed.

Exclusion Criteria:

  1. Patients who have received previous cytotoxic therapy for prostate cancer are ineligible.
  2. Patients who in the judgement of their treating physician will not be able to receive therapy and follow-up according to the protocol guidelines will be ineligible.
  3. Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
  4. History of other primary cancer, unless:

    • Curatively resected non-melanomatous skin cancer
    • Other primary solid tumour curatively treated with no known active disease present and no curative treatment for the last year.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01160705
Other Study ID Numbers CTRIAL-IE (ICORG) 08-08
ICORG-08-08
EU-21044
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cancer Trials Ireland
Study Sponsor Cancer Trials Ireland
Collaborators Not Provided
Investigators
Principal Investigator: Ray McDermott, MD Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
PRS Account Cancer Trials Ireland
Verification Date May 2017