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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 63 days

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

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.

0 / 12Eligibility criteria met

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

379 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 Sep 2025

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