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Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478308
Recruitment Status : Withdrawn (No accrual in initial period, PI decided to close study.)
First Posted : November 23, 2011
Last Update Posted : March 6, 2013
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Metformin hydrochloride Drug: Docetaxel Drug: Prednisone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer
Study Start Date : June 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Metformin hydrochloride
    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.
  • Drug: Docetaxel
    Docetaxel will be administered 75 mg/m2 as one hour infusion on day 1 every 21 days.
  • Drug: Prednisone
    Prednisone will be given 5mg orally twice daily which is the standard regimen with docetaxel

Primary Outcome Measures :
  1. Measure efficacy [ Time Frame: 7 years ]
    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 :
  1. Measure toxicity [ Time Frame: 7 years ]
    To evaluate the quantitative and qualitative toxicities of metformin with this schedule, in this population

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478308

Sponsors and Collaborators
New Mexico Cancer Care Alliance
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Principal Investigator: Richard Lauer, MD University of New Mexico Cancer Center

Additional Information:
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Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT01478308     History of Changes
Other Study ID Numbers: INST 1011
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by New Mexico Cancer Care Alliance:
castration resistant
hormone resistant

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal