Pre-operative Treatment for Patients with Untreated Pancreatic Cancer

Sponsor: HonorHealth Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03138720

Provider View

This study is testing a combination of drugs to see if they are effective in treating pancreatic cancer that can or cannot be removed by surgery. The drugs being tested include paclitaxel protein bound, gemcitabine, cisplatin, and paricalcitol.

Patient Parameters

Program Overview

The study aims to find out if a combination of drugs given before surgery can help control pancreatic cancer. These drugs include paclitaxel protein bound, gemcitabine, cisplatin, and paricalcitol. Researchers want to see if this combination is effective for patients whose cancer can be surgically removed and those whose cancer cannot be removed.

Description

This study is exploring the use of a combination of drugs given before surgery to treat pancreatic cancer. This approach, known as neoadjuvant therapy, is already used for some patients with advanced pancreatic cancer. The drugs being tested include paclitaxel protein bound, gemcitabine, cisplatin, and paricalcitol. Previous studies have shown that using these drugs before surgery can improve survival rates and help shrink tumors, making surgery more successful.

The study will look at how well these drugs work together and if they can improve outcomes for patients with pancreatic cancer. Researchers are particularly interested in seeing if adding cisplatin and paricalcitol to the treatment can enhance its effectiveness. Cisplatin is known to help prevent cancer cells from repairing themselves, while paricalcitol, a form of Vitamin D, may help make the tumor environment less friendly to cancer growth.

Participants in the study will receive the drug combination before surgery, and researchers will monitor their response to the treatment. The goal is to determine if this approach can lead to better survival rates and control of the cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic cancer that can be surgically removed, is borderline removable, or is locally advanced and cannot be removed.
  • Age 18 or older.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • If sexually active, must agree to use effective contraception.
  • No prior chemotherapy or radiation therapy for pancreatic cancer.
  • Normal organ and bone marrow function, including:
    • Neutrophil count of at least 1,500/mm3
    • Platelet count of at least 100,000/mm3
    • Hematocrit level above 27%
    • Normal liver and kidney function tests
  • Acceptable blood clotting status.
  • Karnofsky Performance Status of 70% or higher, indicating the ability to care for oneself.
  • Elevated CA 19-9 levels, a marker often used in pancreatic cancer.

Exclusion Criteria

  • Evidence of cancer spread to other parts of the body.
  • Active, uncontrolled infections requiring treatment.
  • Known infection with HIV, hepatitis B, or hepatitis C.
  • Recent major surgery within 4 weeks before starting the study.
  • Allergy or hypersensitivity to the study drugs.
  • Serious medical conditions affecting major organs.
  • Significant heart rhythm problems.
  • Unable or unwilling to follow study procedures.
  • Participation in another clinical trial.
  • History of certain lung diseases or multiple allergies.
  • Use of non-FDA approved cannabinoids, except for up to 40 mg per day of marinol.

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