Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01666730|
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer||Drug: metformin hydrochloride Drug: oxaliplatin Drug: leucovorin calcium Drug: fluorouracil Other: laboratory biomarker analysis||Phase 2|
I. To determine if metformin (metformin hydrochloride) when added to FOLFOX ( leucovorin calcium, fluorouracil, oxaliplatin) improves overall survival in patients with metastatic pancreatic cancer.
I. To assess response rate (RR). II. To assess progression free survival (PFS). III. To assess toxicity in patients with metastatic pancreatic cancer receiving FOLFOX and metformin. IV. To identify tumor/serum correlative markers.
OUTLINE: Patients receive metformin hydrochloride orally (PO) twice daily (BID) on days 1-7 for an introductory period before the addition of FOLFOX. After the introductory period, patients will continue metformin twice daily and FOLFOX therapy comprising leucovorin calcium intravenously (IV) over 120 minutes, fluorouracil IV continuously over 46 hours, and oxaliplatin IV over 120 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Metformin Plus Modified FOLFOX 6 in Patients With Metastatic Pancreatic Cancer|
|Actual Study Start Date :||February 15, 2013|
|Actual Primary Completion Date :||August 1, 2018|
|Actual Study Completion Date :||February 15, 2019|
Experimental: Treatment (metformin hydrochloride, FOLFOX)
Patients receive metformin hydrochloride PO BID on days 1-14 and FOLFOX therapy comprising leucovorin calcium IV over 120 minutes, fluorouracil IV continuously over 46 hours, and oxaliplatin IV over 120 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Drug: metformin hydrochloride
Other Name: Glucophage
Drug: leucovorin calcium
Other: laboratory biomarker analysis
- Median overall survival (OS) [ Time Frame: Time from first day of treatment to death from any cause, assessed up to 1 year ]Calculated using Kaplan Meier methods and the median will be estimated assuming an exponential distribution.
- Response Rate (RR) objective tumor response based on computed tomography (CT) scans or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 1 year ]The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a >=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria. The true response rate of the combination therapy for this patient population will be estimated based on the number of response using a binomial distribution and its confidence intervals will be estimated using Wilson's method.
- Progression free survival according to RECIST 1.1 Criteria [ Time Frame: Time from first day of treatment received to the earlier documented disease progression or death from any cause, assessed up to 1 year ]Calculated using Kaplan Meier methods and the median will be estimated assuming an exponential distribution.
- Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0 [ Time Frame: Up to 1 year ]The toxicity profile of the combination will be tabulated.
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): NCT01666730
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Smitha Krishnamurthi, MD||University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|