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Anti-metabolites
Combination Chemotherapy + Metformin + Dietary Supplement for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Vincent Chung
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a combination of gemcitabine hydrochloride, nab-paclitaxel, metformin hydrochloride, and a standardized dietary supplement to see how well it works in treating patients with pancreatic cancer that cannot be removed by surgery.
Who is the study for?
This trial is for patients with pancreatic cancer that can't be surgically removed. They should have normal bilirubin and creatinine levels, not be severely ill from other causes, able to swallow pills without vomiting issues, and not pregnant or nursing. Prior chemotherapy is mostly excluded except under certain conditions.
What is being tested?
The trial tests the combination of chemotherapy drugs gemcitabine hydrochloride and nab-paclitaxel with diabetes drug metformin hydrochloride and a dietary supplement mix aimed at targeting various aspects of cancer cell growth in patients with inoperable pancreatic cancer.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Metformin may cause digestive upset or low blood sugar levels. Dietary supplements could also cause unforeseen reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Compliance of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement (percent of patients who are fully compliant)
Feasibility of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement
Toxicity of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement (National Cancer Institute Common Terminology for Adverse Events criteria version 4)
Secondary study objectives
Overall survival
Progression-free survival
Time to treatment failure
Other study objectives
Analysis of biological correlates (Peripheral blood will be evaluated)
Quality of life, assessed using the FACT-G questionnaire
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (gemcitabine, Abraxane, metformin, DS)Experimental Treatment6 Interventions
Patients receive gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15. Patients also receive metformin hydrochloride PO BID starting day -6 and dietary supplement PO BID starting day -3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Paclitaxel Albumin-Stabilized Nanoparticle Formulation
2007
Completed Phase 2
~360
Metformin Hydrochloride
2016
Completed Phase 4
~1990
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,888 Previous Clinical Trials
41,021,137 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
598 Previous Clinical Trials
1,923,355 Total Patients Enrolled
Vincent ChungPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
419 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your bilirubin level is less than 1.4 mg/dl.You need to have a CT or MRI scan done within 4 weeks before joining the study.You are able to perform daily activities with little to no difficulty.Your platelet count is higher than 100,000 per microliter.Your kidney function is good, with a creatinine level less than 1.4 mg/dl or a creatinine clearance greater than 60 cc/min.Your liver enzymes (ALT and AST) should not be more than 3 times the normal limit.Your absolute neutrophil count is higher than 1,500 per microliter.You must have a confirmed diagnosis of pancreatic adenocarcinoma.Your condition cannot be treated with surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (gemcitabine, Abraxane, metformin, DS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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