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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel, carboplatin and metformin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin with standard chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic biomarker evaluation | Glucose (mg/dL) | 3 months |
| Metabolic biomarker evaluation | Fasting insulin (mIU/L) | 3 months |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa N Abaid, M.D., M.P.H. | Contact | 949-642-1361 | Research@gynoncology.com | |
| Katrina Lopez, CCRC | Contact | 949-642-5165 | 259 | Katrinal@gynoncology.com |
| Name | Affiliation | Role |
|---|---|---|
| Lisa N Abaid, M.D., M.P.H. | Gynecologic Oncology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Associates | Recruiting | Newport Beach | California | 92663 | United States |
Data will be shared once all data is reviewed
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D043823 |
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| Paclitaxel | Drug | Standard chemotherapy |
|
|
| Carboplatin | Drug | Standard chemotherapy |
|
|
| Metabolic biomarker evaluation | BMI (kg/m2) | 3 months |
| Metabolic biomarker evaluation | Urine (mOsm/kg) | 3 months |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |