What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as the combination of paclitaxel (protein-bound), gemcitabine, cisplatin, and paricalcitol, are associated with several side effects. Paclitaxel can cause neuropathy, fatigue, and neutropenia. Gemcitabine is known for causing neutropenia, thrombocytopenia, and flu-like symptoms. Cisplatin often leads to nephrotoxicity, ototoxicity, and severe nausea and vomiting. Paricalcitol, while less commonly discussed, may cause hypercalcemia and gastrointestinal disturbances. These side effects necessitate careful monitoring and management during treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of pancreatic cancer, including gemcitabine and nab-paclitaxel. Gemcitabine, a nucleoside analog that inhibits DNA synthesis, was one of the first chemotherapeutic agents approved for pancreatic cancer. Nab-paclitaxel, a nanoparticle albumin-bound formulation of paclitaxel that stabilizes microtubules, was later approved in combination with gemcitabine for metastatic pancreatic cancer, showing improved survival rates. Cisplatin, a platinum-based drug that causes DNA crosslinking, is often used off-label in combination regimens for pancreatic cancer, although it is not specifically FDA-approved for this indication. Paricalcitol, a vitamin D analog, is primarily used for conditions related to calcium and phosphate metabolism and is not FDA-approved for pancreatic cancer treatment, but it is being studied for its potential role in modulating cell proliferation and differentiation in cancer therapy.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) Imidazole derivatives, which target multiple cancer pathways such as microtubules, kinases, and PARP. 2) Combination of gemcitabine with cyclin-dependent kinase inhibitors like P276-00, which enhances gemcitabine's cytotoxicity. 3) Triptolide combined with gemcitabine, which induces DNA double-strand breaks and suppresses checkpoint kinase 1. These alternatives offer diverse mechanisms of action and potential synergistic effects.

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Vitamin D Analog

Chemotherapy + Paricalcitol for Pancreatic Cancer (NABPLAGEMD Trial)

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of 3 cycles (each cycle is 21 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of three chemotherapy drugs and a form of Vitamin D for patients with advanced pancreatic cancer who haven't been treated before. The drugs aim to kill cancer cells and stop their growth, while the Vitamin D helps make the cancer more responsive to treatment. Vitamin D has long been evaluated for benefit as a protective agent and treatment for malignancies, including pancreatic cancer, but there is no clear evidence that supplementation improves outcomes in pancreatic cancer to date.

Who is the study for?

This trial is for adults with untreated metastatic pancreatic ductal adenocarcinoma. Participants must have a life expectancy of at least 12 weeks, measurable tumor lesions, and be able to consent to the study's procedures including biopsies. Women should not be pregnant or breastfeeding and both genders must practice birth control during the study.

What is being tested?

The trial tests if combining paclitaxel protein bound (a chemotherapy drug), gemcitabine, cisplatin (another chemo drug), and paricalcitol can effectively treat individuals with metastatic pancreatic cancer who haven't had previous treatments for their advanced disease.

What are the potential side effects?

Potential side effects may include nausea, fatigue, hair loss from chemotherapy drugs like paclitaxel protein bound and cisplatin; as well as possible kidney issues related to paricalcitol. Each patient's experience with side effects could vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of 3 cycles (each cycle is 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of 3 cycles (each cycle is 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of 3 cycles (each cycle is 21 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

Pathologic Complete Response Rate

Secondary study objectives

Carbohydrate Antigen 19-9 (CA19-9) value

Parathyroid Hormone (PTH)

Vitamin D 25-hydroxy (OH)

+3 more

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: Paricalcitol (Zemplar)Experimental Treatment1 Intervention

Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paricalcitol (Zemplar)

2018

Completed Phase 2

~20

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Paclitaxel protein-bound (nab-paclitaxel) stabilizes microtubules, preventing cell division and leading to cancer cell death. Gemcitabine inhibits DNA synthesis by incorporating itself into the DNA strand, causing cell cycle arrest and apoptosis. Cisplatin forms DNA crosslinks, which disrupt DNA replication and transcription, ultimately leading to cell death. Paricalcitol, a vitamin D analog, modulates cell proliferation and differentiation, potentially reducing tumor growth. These mechanisms are crucial for pancreatic cancer treatment as they target the rapid and uncontrolled cell division characteristic of cancer, aiming to reduce tumor size and spread.

Exceptional Response to Nanoparticle Albumin-Bound Paclitaxel and Gemcitabine in a Patient with a Refractory Adenocarcinoma of the Ampulla of Vater.