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

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ClinicalTrials.gov Identifier: NCT02437812
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Gynecologic Oncology Associates

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
Epithelial Ovarian Carcinoma Drug: Metformin Drug: Paclitaxel Drug: Carboplatin 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : January 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : April 2021


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 Name: Glucophage

Drug: Paclitaxel
Standard chemotherapy
Other Name: Taxol

Drug: Carboplatin
Standard chemotherapy
Other Name: Carbo




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 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 [ Time Frame: 3 months ]
    Glucose (mg/dL)

  2. Metabolic biomarker evaluation [ Time Frame: 3 months ]
    Fasting insulin (mIU/L)

  3. Metabolic biomarker evaluation [ Time Frame: 3 months ]
    BMI (kg/m2)

  4. Metabolic biomarker evaluation [ Time Frame: 3 months ]
    Urine (mOsm/kg)



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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:

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


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): NCT02437812


Contacts
Contact: Lisa N Abaid, M.D., M.P.H. 949-642-1361 Research@gynoncology.com
Contact: Katrina Lopez, CCRC 949-642-5165 ext 259 Katrinal@gynoncology.com

Locations
United States, California
Gynecologic Oncology Associates Recruiting
Newport Beach, California, United States, 92663
Contact: Katrina Lopez, CCRC    949-642-5165 ext 259    Katrinal@gynoncology.com   
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

Responsible Party: Gynecologic Oncology Associates
ClinicalTrials.gov Identifier: NCT02437812     History of Changes
Other Study ID Numbers: GOA-TCOM1
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared once all data is reviewed

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Metformin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs