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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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

Inclusion Criteria:

- All patients, 18 of age or older, with hormone refractory prostate cancer are

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure efficacy

Outcome 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.

Outcome Time Frame:

7 years

Safety Issue:


Principal Investigator

Richard Lauer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Institutional Review Board

Study ID:

INST 1011



Start Date:

June 2011

Completion Date:

October 2011

Related Keywords:

  • Prostate Cancer
  • prostate
  • castration resistant
  • hormone resistant
  • CRPC
  • Prostatic Neoplasms