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Anti-metabolites

Pre-operative 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
Karnofsky Performance Status (KPS) of ≥70%
Age ≥ 18 years
Must not have
History of allergy or hypersensitivity to the study drugs
Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 63 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a combination of four drugs is effective in treating pancreatic cancer.

Who is the study for?
This trial is for adults with pancreatic cancer that can potentially be removed by surgery or is locally advanced but not spread elsewhere. Participants need to have a good performance status, no prior treatments for pancreatic cancer, and normal organ/marrow function. They must agree to use contraception and cannot have any major health risks or infections like HIV.
What is being tested?
The study tests if combining paclitaxel protein bound (Abraxane), gemcitabine, cisplatin, and paricalcitol helps patients with resectable or unresectable pancreatic cancer. It aims to see if this mix of drugs improves the condition before potential surgery.
What are the potential side effects?
Possible side effects include allergic reactions, lowered blood cell counts leading to increased infection risk, fatigue, nausea, kidney problems from cisplatin; nerve damage from paclitaxel; and calcium level changes due to paricalcitol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 am 18 years old or older.
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My pancreatic cancer is confirmed and may or may not be removable by surgery.
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My organ and bone marrow functions are normal.
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I have not had chemotherapy or radiation for pancreatic cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to the medication used in this study.
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I have a history of lung conditions like sarcoidosis or severe allergies.
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I do not have any ongoing serious infections requiring treatment.
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My cancer has spread to other parts of my body.
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I have been diagnosed with HIV, hepatitis B, or hepatitis C.
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I do not have any serious heart rhythm problems.
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I don't use non-FDA approved cannabinoids and use no more than 40 mg of Marinol daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 63 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 63 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CA19-9 value
Secondary study objectives
Overall Survival
Pathologic Complete Response Rate

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: Open LabelExperimental Treatment1 Intervention
All patients will receive open label medication at set dosages unless the dosage needs to be adjusted to treat an adverse event or dose toxicity.

Find a Location

Who is running the clinical trial?

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

Media Library

Paclitaxel Protein Bound (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03138720 — Phase 2
Pancreatic Adenocarcinoma Research Study Groups: Open Label
Paclitaxel Protein Bound (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03138720 — Phase 2
Pancreatic Adenocarcinoma Clinical Trial 2023: Paclitaxel Protein Bound Highlights & Side Effects. Trial Name: NCT03138720 — Phase 2
~3 spots leftby Nov 2025
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