A Phase 2 interventional study of Metformin hydrochloride and Docetaxel in Prostate Cancer, sponsored by New Mexico Cancer Research Alliance. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-06.
Sponsored by New Mexico Cancer Research Alliance · Phase 2, Interventional, and Treatment
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.
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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Exclusion Criteria:
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.
Docetaxel will be administered 75 mg/m2 as one hour infusion on day 1 every 21 days.
Prednisone will be given 5mg orally twice daily which is the standard regimen with docetaxel
Measure efficacy
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.
Time frame: 7 years
Measure toxicity
To evaluate the quantitative and qualitative toxicities of metformin with this schedule, in this population
Time frame: 7 years
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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New Mexico Cancer Research Alliance