← Back to Search

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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

~1430

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,132 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,439 Total Patients Enrolled

Vincent ChungPrincipal InvestigatorCity of Hope Medical Center

9 Previous Clinical Trials

388 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are participating in this experiment?

"This research trial is currently being conducted across 4 separate medical centres, including City of Hope Rancho Cucamonga in California, City of Hope South Pasadena and the City of Hope Medical Center in Duarte. Additionally, there are other locations involved with this study."

Answered by AI

How many participants have enrolled in this experiment?

"Recruitment for this clinical trial has closed, with initial posting on January 14th 2016 and the final update occurring March 17th 2022. For other studies related to pancreatic carcinoma there are 641 active trials currently seeking participants while 1302 more require individuals for Paclitaxel Albumin-Stabilized Nanoparticle Formulation research."

Answered by AI

Is recruitment for this research opportunity open at the moment?

"At this juncture, the trial is not recruiting participants. It was originally posted on January 14th 2016 and last updated on March 17th 2022. If you are in search of other trials, 641 studies for pancreatic carcinoma and 1,302 experiments utilizing Paclitaxel Albumin-Stabilised Nanoparticle Formulation are currently seeking out candidates."

Answered by AI

To what type of ailment is Paclitaxel Albumin-Stabilized Nanoparticle Formulation most regularly prescribed?

"Paclitaxel Albumin-Stabilized Nanoparticle Formulation is a well-known treatment for neoplasm metastasis, but can also be used to alleviate acute pyelonephritis(APN), diet and exercise not sufficient for diabetes control, and shock hypovolemic."

Answered by AI

What investigative evidence has been gathered about the safety of Paclitaxel Albumin-Stabilized Nanoparticle Formulation for human use?

"The safety of Paclitaxel Albumin-Stabilized Nanoparticle Formulation is estimated to be a 1 due to its Phase 1 status, meaning that there is limited evidence supporting the drug's efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery

2016. "Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02336087.

All > Acl > Pancreatic Cancer