Back to resultsMetformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Metformin hydrochloride
Docetaxel
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, castration resistant, hormone resistant, CRPC
Eligibility Criteria
Inclusion Criteria:
- All patients, 18 of age or older, with hormone refractory prostate cancer are eligible.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
- Patients must have pathologically confirmed prostate cancer with PSA increasing despite androgen deprivation therapy.
- Diabetic patients on therapy with Metformin are eligible provided that their Metformin dose is at least 850mg twice daily.
Exclusion Criteria:
- Patients with symptomatic brain metastases are excluded from this study.
- Patients on insulin are not eligible.
- Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus, cardiovascular disease, and congestive heart failure defined as New York Heart Association Class III or IV, hepatic dysfunction, or active infections are not eligible for this trial.
Sites / Locations
Outcomes
Primary Outcome Measures
Measure efficacy
To determine the antitumor activity of metformin in combination with docetaxel and prednisone which are considered standard of care administered to patients with hormone refractory prostate cancer.
Secondary Outcome Measures
Measure toxicity
To evaluate the quantitative and qualitative toxicities of metformin with this schedule, in this population
Full Information
NCT ID
NCT01478308
First Posted
September 2, 2011
Last Updated
March 5, 2013
Sponsor
New Mexico Cancer Care Alliance
1. Study Identification
Unique Protocol Identification Number
NCT01478308
Brief Title
Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer
Official Title
Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No accrual in initial period, PI decided to close study.
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being conducted to determine the effectiveness of standard 3 weekly treatments using docetaxel and prednisone with metformin in patients with castration-resistant metastatic prostate cancer.
It is also being conducted to determine the levels of toxicity of metformin when added to every 3 weekly docetaxel treatments in patients with endocrine resistent, metastatic prostate cancer.
Detailed Description
This is a single-arm, non-randomized Phase II trial of docetaxel given every 3 weeks with metformin twice daily and Prednisone twice daily. The study duration of this trial is open ended. The patient would take the metformin only for as long as they are treated with docetaxel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate, castration resistant, hormone resistant, CRPC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Metformin hydrochloride
Intervention Description
Metformin is administered orally, with food. Metformin tablets contain 500mg, 850mg, or 1000mg of metformin hydrochloride. Tablets contain inactive ingredients including pofidone and magnesium stearate. The coating for 500mg and 850mg tablets contains hypromellose. Metformin is an antihyperglycemic agent which decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.In this study, Metformin will be given 850 mg orally, with food, once daily for 1 week starting the week before first docetaxel infusion, and thereafter 850 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel will be administered 75 mg/m2 as one hour infusion on day 1 every 21 days.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone will be given 5mg orally twice daily which is the standard regimen with docetaxel
Primary Outcome Measure Information:
Title
Measure efficacy
Description
To determine the antitumor activity of metformin in combination with docetaxel and prednisone which are considered standard of care administered to patients with hormone refractory prostate cancer.
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Measure toxicity
Description
To evaluate the quantitative and qualitative toxicities of metformin with this schedule, in this population
Time Frame
7 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients, 18 of age or older, with hormone refractory prostate cancer are eligible.
Patients must have a life expectancy of at least 12 weeks.
Patients must have a Zubrod performance status of 0-2.
Patients must sign an informed consent.
Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
Patients must have pathologically confirmed prostate cancer with PSA increasing despite androgen deprivation therapy.
Diabetic patients on therapy with Metformin are eligible provided that their Metformin dose is at least 850mg twice daily.
Exclusion Criteria:
Patients with symptomatic brain metastases are excluded from this study.
Patients on insulin are not eligible.
Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
Patients with severe medical problems such as uncontrolled diabetes mellitus, cardiovascular disease, and congestive heart failure defined as New York Heart Association Class III or IV, hepatic dysfunction, or active infections are not eligible for this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lauer, MD
Organizational Affiliation
University of New Mexico Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer
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