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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 63 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CA19-9 value

Secondary outcome measures

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 / 5Eligibility 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

Frequently Asked Questions

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

Has Abraxane, a form of Paclitaxel Protein Bound, been accepted by the FDA?

"Abraxane's safety was rated a 2 due to it being in the second phase of its trial, with data supporting its security but none yet indicating efficacy."

Answered by AI

Is it possible for prospective participants to join this trial?

"At this time, the data hosted on clinicaltrials.gov reveals that no further enrolment of participants is required for this trial which was first announced in May 2017 and edited most recently in February 2022. However, there are over two thousand seven hundred fifty-seven other trials currently looking for candidates."

Answered by AI

How many individuals have been recruited for this experiment?

"At this juncture, no new patients are being sought for this trial. Initially posted on May 23rd 2017 and last updated February 15th 2022, if you're looking to join a different clinical trial there are presently 1256 studies recruiting participants with cancer of the pancreas and another 1,501 trials searching for volunteers taking Paclitaxel Protein Bound (Abraxane)."

Answered by AI

How is Paclitaxel Protein Bound (Abraxane) most commonly prescribed?

"Paclitaxel Protein Bound (Abraxane) is generally prescribed to patients who have previously undergone adjuvant anthracycline-containing therapy, however it can also be beneficial for other afflictions like neoplasm metastasis, locally advanced non-small cell lung cancer, and metastatic bladder cancer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pre-operative Treatment for Patients With Untreated Pancreatic Cancer

2017. "Pre-operative Treatment for Patients With Untreated Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03138720.

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