Epithelial Ovarian Carcinoma Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | April 2021 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Gynecologic Oncology Associates | Newport Beach | California |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Associates | University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | 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. | 5 years | |
Secondary | Metabolic biomarker evaluation | Glucose (mg/dL) | 3 months | |
Secondary | Metabolic biomarker evaluation | Fasting insulin (mIU/L) | 3 months | |
Secondary | Metabolic biomarker evaluation | BMI (kg/m2) | 3 months | |
Secondary | Metabolic biomarker evaluation | Urine (mOsm/kg) | 3 months |
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