Status:
COMPLETED
Metformin-Docetaxel Association in Metastatic Hormone-refractory Prostate Cancer
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Prostate cancer is the second leading cause of mortality in men, representing 10 deaths about of 100 cancers (INVS 2009). Treatment for metastatic prostate cancer, when becoming resistant to hormone-t...
Detailed Description
Prostate cancer: the current issues In developed countries, prostate cancer represents a major health issue and its incidence is rising globally, due to an aging society (Ferlay, Autier et al. 2007; D...
Eligibility Criteria
Inclusion
- \- Age \> 18 years
- Histologically confirmed prostate adenocarcinoma.
- Karnofsky Performance Score \> 50%
- Evidence of metastatic disease by the presence of documented locoregional or distant metastases on CT scan of the abdomen and/or pelvis, or bone scintigraphy
- Hormone Resistance Prostate Cancer defined as an increase in PSA level (3 consecutive measurements) after hormonal treatment (surgical castration or androgen blockade)
- No prior chemotherapy (excepted phosphate estramustine or Estracyt®)
- At least one month had to have elapsed between the withdrawal of antiandrogens and enrolment, except LH-RH agonist therapy that must be continued throughout this study.
- Hormonal castration confirmed biologically (testosterone \< 0.5 ng/ml)
- Patient with adequate organ function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Haemoglobin ≥ 9 g/dL
- Platelets (PTL) ≥ 100 x 109/L
- AST - ALAT ≤ 2.5x ULN
- Bilirubin ≤ 1.5 x ULN
- Creatinine \< 150 µmol/l
- Alkaline phosphatases ≤ 2,5 x ULN
- Patient with life expectancy \> 3 months
- Information delivered to patient and informed consent signed by the patient or legal representative
- Patient affiliated with a health insurance system
Exclusion
- The patient with at least one of the following criteria could not be included:
- Age \< 18 years
- Patient with type II or type I diabetes
- Excessive alcohol intake, acute or chronic.
- Patients already treated with Metformin or an analog
- Known hypersensitivity or allergy to Metformin HCl or any of the excipients.
- Patients with a history of lactic acidosis
- PSA increasement without lesions confirmed by radiography and/or bone scan.
- Testosteronemia \> 0.5 ng/ml
- Any radiation within 4 weeks prior to study entry
- Strontium 89 administration within 3 month before inclusion
- Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
- Peripheral neuropathy with grade \> 3 (NCI), unrelated to cancer.
- Patient treated for a cancer other than prostate cancer, with the exception of basal cell carcinoma
- Treatment with any investigational agent
- Treatment on another therapeutic clinical trial within 30 days before enrolment
- Acute or chronic metabolic acidosis
- Patients suffering from severe dehydration
- Permanent contraindication to corticosteroids
- Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol, such as completion of QoL questionnaire.
- Patient enable to give informed consent
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01796028
Start Date
January 1 2013
End Date
May 31 2018
Last Update
June 6 2018
Active Locations (1)
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1
Centre ANTOINE LACASSAGNE
Nice, France, 06189