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Alkylating agents

Chemotherapy for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Erkut Borazanci, MD
Research Sponsored by HonorHealth Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have normal organ and marrow function
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial looks at how well a certain chemotherapy treatment works in shrinking pancreatic tumors before surgery.

Who is the study for?
This trial is for adults with non-metastatic pancreatic cancer who haven't had chemotherapy or radiation. They must have a specific tumor marker elevated, normal organ function, and agree to use contraception if sexually active. Excluded are those with certain infections, recent major surgery, allergies to study drugs, lung conditions, heavy cannabinoid use, or other serious health risks.Check my eligibility
What is being tested?
The trial tests a combination of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydroxychloroquine in patients with pancreas cancer. It aims to see how this regimen affects the CA 19-9 tumor marker after up to six months before surgery.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, nerve damage (neuropathy), low blood counts leading to increased infection risk or bleeding problems due to Cisplatin and Gemcitabine; skin rash from Hydroxychloroquine; and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs and bone marrow are functioning normally.
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I am 18 years old or older.
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My blood clotting status is within the safe range.
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My pancreatic cancer is confirmed and may or may not be removable by surgery.
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I am able to care for myself but may not be able to do active work.
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I have not had chemotherapy or radiation for pancreatic cancer.
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My CA 19-9 levels are high, but my bilirubin is normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Normalization Rate of CA 19-9
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events
Resectability Rate
Response Rate
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment4 Interventions
Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Hydroxychloroquine
2017
Completed Phase 4
~5630
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

HonorHealth Research InstituteLead Sponsor
25 Previous Clinical Trials
887 Total Patients Enrolled
Erkut Borazanci, MDPrincipal InvestigatorHonorHealth Research Institute
7 Previous Clinical Trials
384 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04669197 — Phase 2
Pancreatic Cancer Research Study Groups: Treatment
Pancreatic Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04669197 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04669197 — Phase 2

Frequently Asked Questions

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

How many participants have been accepted for this investigation?

"Affirmative. Per the information posted on clinicaltrials.gov, this medical research is presently looking for participants; it was initially advertised on December 1st 2020 and updated most recently in May 10th 2022. 12 individuals are needed from one research centre."

Answered by AI

Are there any spots left for participants in this clinical experiment?

"Clinicaltrials.gov documents that this clinical trial is active and recruiting, having first been posted on 12/1/2020 with the most recent edit made on 5/10/2022."

Answered by AI

Has this particular treatment obtained regulatory endorsement from the FDA?

"The safety of the proposed intervention is estimated at a 2 because this is just a Phase 2 clinical trial, meaning there only exists some evidence supporting its security but none regarding efficacy."

Answered by AI

What diseases may this remedy be applied to?

"This treatment is primarily used to manage and slow the progression of neoplasm metastasis. Additionally, it can be prescribed for a range of ailments such as malaria, kaposi sarcoma, and advance directives."

Answered by AI
~4 spots leftby Mar 2025