Phase Ib/II study of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer

niversity Medical Center Groningen0 sites124 target enrollmentMarch 19, 2014

Overview

No summary available.

Registry

who.int

Start Date

March 19, 2014

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Inclusion criteria
•Patients with advanced stage (FIGO III\-IV), histologically confirmed and documented epithelial ovarian carcinoma
•Patients eligible for neoadjuvant carboplatin/paclitaxel chemotherapy prior to surgical debulking (phase 1 or 2\) OR patients with relapsed or progressive ovarian cancer after first line treatment eligible for palliative carboplatin/paclitaxel chemotherapy (phase 1 only)
•If an exploratory laparotomy was performed at diagnosis, patients are only eligible if aggressive tumour debulking procedures were not performed. Only minimal tumour resection for the purpose of diagnosis and palliation are allowed. Aggressive tumour debulking procedures include total abdominal hysterectomy, bilateral salpingo\-oophorectomy and omentectomy, with or without lymphadenectomy (phase 2 only)
•Measurable tumour according to RECISTv1\.1 or GCIG CA125 criteria (phase 2 only)
•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

•Exclusion criteria
•Prior chemotherapy, immunotherapy, targeted agents or radiotherapy to abdomen or pelvis (phase 2 only)
•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.
•Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer (phase 2 only)
•Symptomatic CNS metastasis
•Pre\-existing peripheral neuropathy \= 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.