Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/11/2016 |
| Start Date: | January 2014 |
| End Date: | April 2021 |
| Contact: | Lisa N Abaid, M.D., M.P.H. |
| Email: | Research@gynoncology.com |
| Phone: | 949-642-1361 |
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.
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.
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.
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.
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
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