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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

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Overall survival
Progression-free survival
Time to treatment failure
Other outcome measures
Analysis of biological correlates (Peripheral blood will be evaluated)
Quality of life, assessed using the FACT-G questionnaire

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
~1440

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,380 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
575 Previous Clinical Trials
1,922,685 Total Patients Enrolled
Vincent ChungPrincipal InvestigatorCity of Hope Medical Center
10 Previous Clinical Trials
407 Total Patients Enrolled

Media Library

Gemcitabine Hydrochloride (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02336087 — Phase 1
Pancreatic Adenocarcinoma Research Study Groups: Treatment (gemcitabine, Abraxane, metformin, DS)
Pancreatic Adenocarcinoma Clinical Trial 2023: Gemcitabine Hydrochloride Highlights & Side Effects. Trial Name: NCT02336087 — Phase 1
Gemcitabine Hydrochloride (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02336087 — Phase 1
~2 spots leftby Jul 2025