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Metabolic Pathway Analysis for Pancreatic Cancer

N/A

Recruiting

Led By Howard S Hochster, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed pancreatectomy

Pancreatic adenocarcinoma patients previously diagnosed by biopsy, who are candidates for intended curative resection either with or without neoadjuvant chemotherapy

Must not have

Concomitant active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at what nutrients pancreatic cancer cells need to survive and how they get them. Researchers will give patients U-13C-glucose during surgery and then study the cancer cells in the lab. This may help researchers understand how cancer cells get nutrients and why they are different from normal cells.

Who is the study for?

This trial is for adults with pancreatic adenocarcinoma, eligible for surgery. It includes both untreated patients and those who've had chemotherapy but no other cancer treatments like radiation or immunotherapy. Participants must understand the study's experimental nature and consent to biopsies during surgery.

What is being tested?

The trial studies how pancreatic cancer cells manage nutrients by using a special form of glucose given during surgery. Researchers will compare the metabolism of cancerous and normal cells from biopsies to better understand the disease.

What are the potential side effects?

Since this trial involves standard surgical procedures and biopsies, potential side effects include typical surgical risks such as infection, bleeding, pain at the incision site, and possible complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to have extra biopsies taken during my surgery for research.

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I have pancreatic cancer and am a candidate for surgery aimed at curing it, with or without prior chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another active cancer besides the one being treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To measure glycolysis metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS)

Secondary study objectives

To measure lipid metabolic dependencies via liquid chromatography-mass spectrometry (LC-MS)

Other study objectives

To measure amino acid metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS)

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: Basic science (uniformly-labeled [13C]glucose)Experimental Treatment3 Interventions

Patients receive uniformly-labeled \[13C\]glucose IV over 10 minutes and then over up to 120 minutes until time of biopsy. Patients then undergo surgery and biopsy per standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9630

Biopsy

2014

Completed Phase 4

~1150