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Study of Metformin With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer (OVMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02312661
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. M. Jalving, University Medical Center Groningen

Brief Summary:
Molecularly targeted agents which inhibit the mammalian target of rapamycin (mTOR) pathway and/or circumvent p53 in the induction of apoptosis are exciting potential targets in ovarian cancer. Metformin is a biguanide, widely used in the treatment of type 2 diabetes mellitus, that has shown anti-cancer activity in preclinical studies. The main mechanism of metformin's effect is mTOR pathway inhibition and, in addition, it has been shown to circumvent p53-induced apoptosis making it an exciting, potentially effective drug in ovarian cancer.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Drug: Metformin Drug: Carboplatin Drug: Paclitaxel Phase 1

Detailed Description:
A phase Ib, single-centre, dose-escalation trial with a traditional escalation rule with fixed dose levels ("3 + 3" rule). The recommended phase II dose will be defined as the maximum predefined dose level at which 0 of 3 or ≤ 1 of 6 subjects experience a drug-related dose limiting toxicity (DLT) during cycle 1 and 2 of treatment. An estimated 10-20 patients will be required for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Study of Metformin in Combination With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer
Actual Study Start Date : October 5, 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: Carboplatin / paclitaxel /metformin
Three-weekly cycles of carboplatin/paclitaxel chemotherapy in combination with metformin treatment
Drug: Metformin
Metformin in increasing doses will be added to carboplatin/paclitaxel chemotherapy

Drug: Carboplatin
Intravenous carboplatin chemotherapy in three-weekly cycles, for a maximum of 6 cycles

Drug: Paclitaxel
Intravenous paclitaxel chemotherapy in three-weekly cycles, for a maximum of 6 cycles




Primary Outcome Measures :
  1. Number of participants with Adverse Events as a measure of safety and tolerability [ Time Frame: 1-2 years ]
    Data will be used to determine recommended phase 2 dose


Secondary Outcome Measures :
  1. Pharmacokinetics (AUC, Tmax,Cmax) of carboplatin and paclitaxel chemotherapie [ Time Frame: 1-2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312661


Locations
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Netherlands
University Mecdical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
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Responsible Party: Dr. M. Jalving, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02312661    
Other Study ID Numbers: 30102012
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Keywords provided by Dr. M. Jalving, University Medical Center Groningen:
ovarian cancer
metformin
carboplatin
paclitaxel
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Metformin
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs