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Status:

COMPLETED

Metformin Hydrochloride as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer

Lead Sponsor:

Swiss Cancer Institute

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Metformin hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for cell growth and stop the growth of tumor cells. PURPOSE: This phase II trial is study...

Detailed Description

OBJECTIVES: * To determine the activity and safety of metformin hydrochloride as first-line therapy in patients with locally advanced or metastatic castration-resistant prostate cancer. OUTLINE: Thi...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the prostate
  • Locally advanced or metastatic disease with no curative therapy possible
  • PSA progression defined as the following:
  • Increase in PSA of ≥ 25% (and an absolute increase of ≥ 2 ng/mL) over nadir value on hormonal therapy measured on 3 successive occasions at least 1 week apart
  • If the third measurement is not higher than the second, a fourth measurement will be taken and only if the fourth measurement is higher than the second, the patient may be enrolled
  • PSA doubling time ≥ 55 days (if used to define progression, must not be older than 6 months)
  • PSA \< 114 ng/mL
  • Testosterone level ≤ 1.7 nmol/L (≤ 50 ng/dL) after at least 1 hormonal treatment (orchiectomy or luteinizing hormone-releasing hormone \[LHRH\] agonist)
  • Patients who have not undergone surgical castration must continue LHRH agonist therapy during study treatment
  • Oligosymptomatic or asymptomatic in relation to disease
  • No known or suspected CNS metastases
  • PATIENT CHARACTERISTICS:
  • WHO performance status 0-1
  • Hemoglobin ≥ 90 g/L
  • Neutrophil count ≥ 1.5 x 10\^9/L
  • Platelet count ≥ 100 x 10\^9/L
  • AST ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • Compliant and geographically proximal for proper staging and follow-up
  • No previous malignancy within the past 2 years except for localized nonmelanoma skin cancer or Ta or Tis bladder cancer
  • No history of diabetic ketoacidosis, diabetic coma, or pre-coma
  • No known history of HIV, hepatitis B, or hepatitis C positivity
  • No known hypersensitivity to the trial drug or any of its components
  • No serious underlying medical condition that, in the judgment of the investigator, would impair the ability of the patient to participate in the trial (e.g., uncontrolled or acute severe infection, uncontrolled diabetes, advanced chronic obstructive pulmonary disease \[COPD\], or heart failure)
  • No psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with compliance for oral drug intake
  • No known alcohol abuse
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • At least 6 weeks since prior antiandrogen therapy and without withdrawal response
  • At least 30 days since prior treatment in another clinical trial
  • At least 4 weeks since prior major surgery
  • At least 4 weeks since prior products known to affect PSA levels
  • At least 2 weeks since prior local radiation
  • No prior chemotherapy, radioisotopes, small molecules, or immunotherapy for prostate cancer
  • No prior metformin hydrochloride
  • No concurrent pharmacotherapy for diabetes mellitus
  • No concurrent finasteride, dutasteride, ketoconazole, or abiraterone acetate
  • No concurrent corticosteroids with an equivalent dose of \> 7.5 mg of prednisolone
  • No concurrent radiotherapy
  • No bisphosphonates started after registration
  • No concurrent drugs contraindicated for use with the trial drug according to the Swissmedic approved product information
  • No other concurrent anticancer drugs
  • No other concurrent experimental or investigational drugs

Exclusion

    Key Trial Info

    Start Date :

    December 23 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 9 2019

    Estimated Enrollment :

    44 Patients enrolled

    Trial Details

    Trial ID

    NCT01243385

    Start Date

    December 23 2010

    End Date

    August 9 2019

    Last Update

    August 13 2019

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Kantonsspital Aarau

    Aarau, Switzerland, CH-5001

    2

    Universitaetsspital-Basel

    Basel, Switzerland, CH-4031

    3

    Inselspital Bern

    Bern, Switzerland, CH-3010

    4

    Kantonsspital Graubuenden

    Chur, Switzerland, CH-7000