Metformin Hydrochloride, Carboplatin, and Paclitaxel in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT02050009|
Recruitment Status : Withdrawn (study was never opened to accrual)
First Posted : January 30, 2014
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Papillary Serous Carcinoma Ovarian Serous Cystadenocarcinoma Recurrent Fallopian Tube Cancer Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Recurrent Primary Peritoneal Cavity Cancer||Drug: metformin hydrochloride Drug: carboplatin Drug: paclitaxel Other: laboratory biomarker analysis||Phase 1|
I. To determine the duration of response to metformin (metformin hydrochloride), carboplatin and paclitaxel followed by maintenance with metformin as compared to the primary duration of remission in within patient controls.
I. Determine the in situ effects of metformin on lethal-7 (let-7) expression as determined by in situ hybridization. (Phase Ia) II. To determine the feasibility of using a core biopsy to perform ribonucleic acid (RNA) sequencing. (Phase Ia) III. To determine epigenomic effects of metformin via RNA-sequencing (Seq). (Phase Ia) IV. To determine the biologic effects of metformin through evaluation of pre and post metformin tumor samples for phosphorylated (p) adenosine monophosphate (AMP)-activated protein kinase (AMPK), v-myc myelocytomatosis viral oncogene homolog (avian) (myc), mechanistic target of rapamycin (mTOR) and phosphorylated v-akt Murine Thymoma Viral Oncogene Homolog 1 (pAKT). (Phase Ia) V. To assess safety and tolerability of metformin and carboplatin and paclitaxel in patients with platinum sensitive recurrent ovarian cancer. (Phase Ib)
Phase Ia: Patients receive metformin hydrochloride orally (PO) once daily (QD) on days 1-7 and twice daily (BID) on days 8-21.
Phase Ib: Patients receive metformin hydrochloride BID on days 1-21, paclitaxel intravenously (IV) over 3 hours on day 1, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use and Safety of Metformin, Carboplatin and Paclitaxel in Non-Diabetic Patients With Recurrent, Platinum Sensitive Ovarian Cancer and the Feasibility of Using a Core Biopsy for RNA-Seq|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 31, 2014|
Experimental: Treatment (metformin hydrochloride, carboplatin, paclitaxel)
Patients receive metformin hydrochloride BID on days 1-21, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: metformin hydrochloride
Other Name: Glucophage
Other: laboratory biomarker analysis
- Probability of successes in patients receiving the combination therapy [ Time Frame: Up to 2 years ]Success for a patient is defined as having a length of remission/progression free survival following this combination therapy that is longer than the length of remission/progression free survival resulting from their immediately prior line of treatment. A one-sided, one sample test of the binomial proportion will be conducted.
- Time to progression [ Time Frame: Time from first documentation of recurrence, to the first documentation of progression after initiating on this trial, assessed up to 2 years ]Summarized using Kaplan-Meier methods.
- Response rate defined by the RECIST [ Time Frame: Up to 2 years ]Computed along with 95% two-sided confidence intervals.
- Progression free survival [ Time Frame: Up to 4 years ]Summarized using Kaplan-Meier methods.
- Overall survival [ Time Frame: Up to 4 years ]Summarized using Kaplan-Meier methods.
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): NCT02050009
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Angela Jain||Fox Chase Cancer Center|