Study on Alternating Chemotherapy Treatments for Untreated Pancreatic Cancer

Sponsor: Lyudmyla Berim

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04672005

Provider View

This clinical trial is testing whether alternating two chemotherapy treatments, modified FOLFIRINOX and a combination of Gemcitabine and Nab-Paclitaxel, can extend the time before treatment failure in patients with untreated metastatic pancreatic cancer.

Patient Parameters

Program Overview

The main goal of this study is to find out if using two different chemotherapy treatments alternately can help patients with untreated metastatic pancreatic cancer have a longer period before their treatment stops working. The study compares this new approach to the current standard treatment, which uses only one of these chemotherapy regimens. Researchers will measure how long it takes for the cancer to progress, for the patient to stop treatment due to side effects, or for the patient to pass away.

Description

This study aims to see if alternating between two chemotherapy treatments, modified FOLFIRINOX (mFFX) and a combination of Gemcitabine and Nab-Paclitaxel (mGnabP), can provide better outcomes for patients with metastatic pancreatic cancer. The primary focus is on the time to treatment failure, which includes cancer progression, stopping treatment due to side effects, or death.

Secondary goals include:

  • Measuring how many patients experience a reduction in tumor size.
  • Determining how long patients live without the cancer getting worse.
  • Assessing overall survival rates.
  • Monitoring changes in a cancer marker called CA-19.9.
  • Evaluating the safety and side effects of the treatment.
  • Checking patients' quality of life during treatment.

Researchers will also explore the genetic makeup of tumors before treatment and analyze blood markers to predict treatment response and detect early signs of cancer progression.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic adenocarcinoma.
  • Cancer has spread to other parts of the body (Stage IV).
  • No previous treatment for metastatic cancer, except certain chemotherapy used with radiation.
  • Good overall health with an ECOG performance status of 0 or 1.
  • At least 18 years old.
  • Have measurable or evaluable cancer.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Adequate blood, liver, and kidney function as shown by specific lab tests.
  • Ability to understand the study and provide informed consent.
  • Willing to follow study procedures and attend scheduled visits.

Exclusion Criteria

  • Have a different type of pancreatic cancer or other specific cancers.
  • Any condition that poses a high risk if participating in the study.
  • Cancer has spread to the brain.
  • Life expectancy less than 12 weeks.
  • Pregnant or breastfeeding.
  • Severe nerve damage.
  • Significant heart disease or recent heart attack.
  • Recent major surgery without full recovery.
  • Other active cancers, except certain treated cancers.
  • Active infections or uncontrolled infections like HIV, Hepatitis B, or C.
  • Allergies to study drugs.
  • Lung diseases or conditions causing breathing issues.
  • Any medical or psychiatric condition that would interfere with the study.

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