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Anti-metabolites

Gemcitabine + Monoclonal Antibody for Pancreatic Cancer

Phase 2

Waitlist Available

Research Sponsored by Brown University

Eligibility Criteria Checklist

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

Must have

Histologically proven metastatic pancreatic cancer with overexpression of HER2/neu

Performance status ECOG 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well gemcitabine and trastuzumab work in treating patients with metastatic pancreatic cancer that overexpresses HER2/neu.

Who is the study for?

This trial is for adults over 18 with metastatic pancreatic cancer that has a specific protein, HER2/neu. They should be relatively healthy (ECOG 0-2), not pregnant, and willing to use contraception. People can't join if they've had certain heart problems, previous treatments with trastuzumab or anthracyclines, other recent chemotherapy or radiotherapy, or are living outside the US.Check my eligibility

What is being tested?

The study tests combining gemcitabine (a chemotherapy drug) with trastuzumab (a monoclonal antibody) in patients whose pancreatic cancer cells have too much of a protein called HER2/neu. It's a Phase II trial aiming to see how effective this combo is at killing tumor cells.See study design

What are the potential side effects?

Possible side effects include allergic reactions to the drugs, damage to normal cells causing low blood counts leading to increased infection risk and bleeding issues, fatigue from treatment stress on the body, and potential harm to heart function.

Eligibility Criteria

Inclusion Criteria

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

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My pancreatic cancer is advanced and tests show high levels of HER2.

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I am able to get out of my bed or chair and move around.

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I am over 18 years old.

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My tests show high HER2 levels in my blood, but there wasn't enough tissue to test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,112 Total Patients Enrolled

Brown UniversityLead Sponsor

456 Previous Clinical Trials

563,040 Total Patients Enrolled

Howard Safran, MDStudy ChairBrown University

30 Previous Clinical Trials

892 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00003797 — Phase 2

Pancreatic Cancer Research Study Groups:

Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT00003797 — Phase 2

Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003797 — Phase 2

Frequently Asked Questions

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

Is it still possible to enroll in this research endeavor?

"According to the details posted on clinicaltrials.gov, the recruitment period for this trial has now ended; it was first announced in March 1999 and last updated in December 2013. Despite not accepting new participants at this time there are 699 other trials currently seeking volunteers."

Answered by AI

In what kind of geographical areas is this research endeavor being conducted?

"The list of 12 clinical trial sites includes Rush-Presbyterian-St. Luke's Medical Center, Memorial Sloan-Kettering Cancer Center and the Cancer Institute of New jersey in addition to nine other medical centres."

Answered by AI

What assurances can be provided regarding the safety of this treatment?

"Our team at Power rated the safety of this treatment a 2 due to limited efficacy data but some indication that it is safe given its status as a Phase 2 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas

1999. "Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00003797.

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