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

NCT01478308 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-03-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Richard Lauer, MD · University of New Mexico Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478308 on ClinicalTrials.gov