NCT01478308

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-11-23
• Last updated: 2013-03-06