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

This study has been withdrawn prior to enrollment.
(No accrual in initial period, PI decided to close study.)
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance Identifier:
First received: September 2, 2011
Last updated: March 5, 2013
Last verified: March 2013

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 Intervention Phase
Prostate Cancer
Drug: Metformin hydrochloride
Drug: Docetaxel
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer

Resource links provided by NLM:

Further study details as provided by New Mexico Cancer Care Alliance:

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

Enrollment: 0
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01478308

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

Additional Information:
Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT01478308     History of Changes
Other Study ID Numbers: INST 1011
Study First Received: September 2, 2011
Last Updated: March 5, 2013

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal processed this record on March 28, 2017