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Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma

Sponsor
Gynecologic Oncology Associates (Other)
Overall Status
Unknown status
CT.gov ID
NCT02437812
Collaborator
University of North Carolina, Chapel Hill (Other)
30
Enrollment
1
Location
1
Arm
87
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Initially, the prospect of metformin as a neoplastic treatment was considered for malignancies of the prostate, colon and pancreas. However, only select clinical studies involving the use of metformin in the treatment of ovarian cancer have documented improved survival rates. Since no first line regimen has demonstrated compelling superiority in the management of advanced stage ovarian carcinoma, the combination of paclitaxel, carboplatin, and metformin is of particular interest given the triplet's prospect for achieving increased synergy without compromising patient tolerability.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

A phase II, open-label, non-randomized, pilot study assessing the safety, toxicity, and progression free survival of advanced stage ovarian carcinoma patients who underwent treatment with paclitaxel, carboplatin and metformin. An estimated 30 patients will be required for this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Open-Label, Non-Randomized, Pilot Study of Paclitaxel, Carboplatin and Oral Metformin for Patients Newly Diagnosed With Stage II-IV Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paclitaxel, carboplatin and metformin

Drug: Metformin (850 mg) Drug: Carboplatin (AUC 5 or 6) Drug: Paclitaxel (80 mg/m2) The regimen will be administered as a dose dense schedule.

Drug: Metformin
Metformin with standard chemotherapy
Other Names:
  • Glucophage

    • Drug: Paclitaxel
    Standard chemotherapy
    Other Names:
  • Taxol

    • Drug: Carboplatin
    Standard chemotherapy
    Other Names:
  • Carbo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival [5 years]

      The primary outcome of progression free survival will compare the percentage of those who have either progressed or died at 1 year with those who were at risk for at least 1 year.

    Secondary Outcome Measures

    1. Metabolic biomarker evaluation [3 months]

      Glucose (mg/dL)

    2. Metabolic biomarker evaluation [3 months]

      Fasting insulin (mIU/L)

    3. Metabolic biomarker evaluation [3 months]

      BMI (kg/m2)

    4. Metabolic biomarker evaluation [3 months]

      Urine (mOsm/kg)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Female Gender

    Age greater than 18 years

    Advanced stage epithelial ovarian, fallopian tube, or primary peritoneal cancer

    Adequate bone marrow function

    ECOG performance score of 2 or greater

    Patients must be able to swallow oral medication.

    Exclusion Criteria:

    Subjects must NOT be taking metformin or have been on metformin in the past 6 months.

    Subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas)

    Subjects with concomitant malignancy or a previous malignancy within the past three years, melanoma skin cancer excepted

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gynecologic Oncology Associates Newport Beach California United States 92663

    Sponsors and Collaborators

    • Gynecologic Oncology Associates
    • University of North Carolina, Chapel Hill

    Investigators

    • Principal Investigator: Lisa N Abaid, M.D., M.P.H., Gynecologic Oncology Associates

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynecologic Oncology Associates
    ClinicalTrials.gov Identifier:
    NCT02437812
    Other Study ID Numbers:
    • GOA-TCOM1
    First Posted:
    May 8, 2015
    Last Update Posted:
    Feb 28, 2017
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Carcinoma
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Metformin
    Paclitaxel
    Carboplatin

    Study Results

    No Results Posted as of Feb 28, 2017