Epithelial Ovarian CarcinomaPhase 2NCT02437812
Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma
A Phase 2 study testing Metformin, Paclitaxel and Carboplatin in people with Epithelial Ovarian Carcinoma, run by Gynecologic Oncology Associates at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Carcinoma
- What is being tested?
- Metformin, Paclitaxel and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gynecologic Oncology Associates
Newport Beach, California, 92663
Katrina Lopez, CCRC, 949-642-5165 ext. 259, Katrinal@gynoncology.com
About this study
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.
Read the 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.
- Conditions
- Epithelial Ovarian Carcinoma
- Being tested
- Metformin, Paclitaxel, Carboplatin
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Metformin with standard chemotherapy
PaclitaxelDrug
Also called Taxol
Standard chemotherapy
CarboplatinDrug
Also called Carbo
Standard chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metformin; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (4)
Metabolic biomarker evaluation
Glucose (mg/dL)
Measured: 3 months
Metabolic biomarker evaluation
Fasting insulin (mIU/L)
Measured: 3 months
Metabolic biomarker evaluation
BMI (kg/m2)
Measured: 3 months
Metabolic biomarker evaluation
Urine (mOsm/kg)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJan 2014
- Primary completionOct 2017 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Associates
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Lisa N Abaid, M.D., M.P.H., Principal investigator, Gynecologic Oncology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437812
- Sponsor's protocol ID
- GOA-TCOM1
- Status last verified
- Aug 2016
- First submitted
- 21 Apr 2015
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be shared once all data is reviewed
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02437812
- Acronym / sponsor ID
- GOA-TCOM1
- Conditions
- Epithelial Ovarian Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gynecologic Oncology AssociatesUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Jan 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel, carboplatin and metformin | Experimental | Drug: Metformin, Drug: Paclitaxel, Drug: CarboplatinDrug: Metformin (850 mg) Drug: Carboplatin (AUC 5 or 6) Drug: Paclitaxel (80 mg/m2) The regimen will be administered as a dose dense schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: GlucophageMetformin with standard chemotherapy | Drug | Paclitaxel, carboplatin and metformin |
| PaclitaxelAlso: TaxolStandard chemotherapy | Drug | Paclitaxel, carboplatin and metformin |
| CarboplatinAlso: CarboStandard chemotherapy | Drug | Paclitaxel, carboplatin and metformin |
Primary outcome
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.
4 secondary outcomes
Metabolic biomarker evaluation
Time frame: 3 months
Metabolic biomarker evaluation
Time frame: 3 months
Metabolic biomarker evaluation
Time frame: 3 months
Metabolic biomarker evaluation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: Yes. Data will be shared once all data is reviewed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa N Abaid, M.D., M.P.H. principal investigator
Gynecologic Oncology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin, Paclitaxel and Carboplatin in people with Epithelial Ovarian Carcinoma, run by Gynecologic Oncology Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa N Abaid, M.D., M.P.H. (949-642-1361, Research@gynoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.