Clinical trial NCT02312661 (phase 1, status: completed)
Conditions: epithelial ovarian cancer
ICD codes: H18.523, H18.521, H18.522, H18.529
Drugs: metformin, carboplatin, paclitaxel
SMILES: CSCC[C@H](N)C(O)=O, N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with advanced stage (FIGO III-IV), histologically confirmed and documented
             epithelial ovarian carcinoma

          -  Patients eligible for neo-adjuvant carboplatin/paclitaxel chemotherapy prior to
             surgical debulking OR patients with relapsed or progressive ovarian cancer after
             initial treatment eligible for palliative carboplatin/paclitaxel chemotherapy

          -  Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0-2

          -  Age ≥ 18 years

          -  Laboratory Requirements - within 7 days prior to enrolment:

          -  absolute neutrophil count (ANC) ≥1.5 x 109/L

          -  platelets > 100 x 109/L

          -  hemoglobin >9g/dl. Patients may be transfused or use erythropoietin to maintain
             hemoglobin values ≥ 9 g/dl.

          -  hepatic function: bilirubin ≤1.5×upper limit of normal (ULN), aspartate
             aminotransferase (AST)/ALT≤2.5×ULN

          -  estimated creatinine clearance ≥ 60ml/min

          -  Before patient registration/randomization, written informed consent for the trial must
             be given according to International Conference on Harmonisation (ICH)/ good clinical
             practice (GCP), and national/local regulations.

        Exclusion Criteria:

          -  Current or recent (within 30 days of first study dosing) treatment with another
             investigational drug or participation in another investigational study.

          -  Metformin within 4 weeks prior to enrolment.

          -  Symptomatic central nervous system (CNS) metastasis

          -  Pre-existing peripheral neuropathy ≥ Common toxicity criteria (CTC) grade 2.

          -  Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior
             to study treatment start, or within 14 days with a confirmatory urine pregnancy test
             within 7 days prior to study treatment start.

          -  Women of childbearing potential (defined as <2 years after last menstruation and not
             surgically sterile) not using effective, non-hormonal means of contraception
             (intrauterine contraceptive device, barrier method of contraception in conjunction
             with spermicidal jelly) during the study and for 6 months after the last study
             medication.

          -  Known hypersensitivity to any of the study drugs or excipients.

          -  Serious active infection requiring i.v. antibiotics at enrolment.

          -  Unstable medical conditions.

          -  Evidence of any other medical conditions, physical examination or laboratory findings
             that may interfere with the planned treatment, affect patient compliance or place the
             patient at high risk from treatment related complications.