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Disodium Levofolinate

Disodium Levofolinate, also known as Sodium Levofolinate or Levoleucovorin Disodium, is a medication being studied in clinical trials for various types of cancer. This article explores its use in combination with other drugs for treating conditions such as metastatic esophageal cancer, colon cancer, and pancreatic cancer. We’ll examine how researchers are investigating its potential to improve treatment outcomes and patient quality of life.

Table of Contents

What is Disodium Levofolinate?

Disodium Levofolinate, also known as Sodium Levofolinate or Levoleucovorin Disodium, is a medication used in cancer treatment[1]. It belongs to a class of drugs called folic acid analogues, which are substances that mimic the action of folic acid in the body[2].

Medical Uses

Disodium Levofolinate is primarily used in the treatment of various types of cancer, including:

  • Colorectal cancer: Particularly in stage II and III colon cancer[2]
  • Pancreatic cancer: Specifically in metastatic pancreatic ductal adenocarcinoma[3]
  • Esophageal cancer: Used in combination with other chemotherapy drugs for metastatic esophageal carcinoma[1]

How It Works

Disodium Levofolinate works by enhancing the effects of certain chemotherapy drugs, particularly 5-fluorouracil (5-FU). It helps to increase the effectiveness of these drugs in killing cancer cells while potentially reducing some of their side effects[2].

Administration

Disodium Levofolinate is typically administered through intravenous infusion. The dosage and frequency of administration can vary depending on the specific cancer type and treatment regimen. In some clinical trials, it has been used at doses up to 200 mg/m² (milligrams per square meter of body surface area)[1][3].

Current Clinical Trials

Several ongoing clinical trials are investigating the use of Disodium Levofolinate in combination with other cancer treatments:

  1. A study for patients with metastatic esophageal carcinoma, combining Disodium Levofolinate with pembrolizumab, lenvatinib, and chemotherapy[1].
  2. A trial for patients with stage III and high-risk stage II colon cancer, using a personalized approach based on blood and tumor characteristics[2].
  3. A study for patients with metastatic pancreatic ductal adenocarcinoma, combining Disodium Levofolinate with mitazalimab and chemotherapy[3].

Potential Side Effects

While specific side effects of Disodium Levofolinate are not detailed in the provided information, patients should be aware that all medications can cause side effects. Common side effects associated with cancer treatments may include:

  • Nausea and vomiting
  • Fatigue
  • Changes in blood cell counts
  • Diarrhea

It’s important to discuss potential side effects with your healthcare provider[3].

Precautions and Contraindications

Patients should inform their healthcare provider about any existing medical conditions or medications they are taking. Some precautions and contraindications may include:

  • Known DPD (DihydroPyrimidine Dehydrogenase) deficiency[2]
  • Pregnancy or breastfeeding[1][2][3]
  • History of certain autoimmune diseases or immunodeficiencies[1]
  • Liver or kidney problems[3]

Always consult with your healthcare provider for personalized advice and information about Disodium Levofolinate and its use in your specific treatment plan.

Trial Name Cancer Type Treatment Combination Primary Objectives
2022-501342-29-00 Metastatic Esophageal Carcinoma Disodium Levofolinate with Pembrolizumab, Lenvatinib, and Chemotherapy Evaluate safety, tolerability, and overall survival
2023-509851-15-00 Stage III and High-Risk Stage II Colon Cancer Disodium Levofolinate with personalized ctDNA-guided treatment Improve clinical outcomes compared to conventional adjuvant chemotherapy
2024-514905-79-00 Metastatic Pancreatic Ductal Adenocarcinoma Disodium Levofolinate with Mitazalimab and Chemotherapy Determine recommended Phase 2 dose and assess clinical activity

FAQ

  • What is Disodium Levofolinate? Disodium Levofolinate is a medication also known as Sodium Levofolinate or Levoleucovorin Disodium. It's a form of folic acid that's being studied in clinical trials for cancer treatment, often used in combination with other chemotherapy drugs.
  • What types of cancer are being studied with Disodium Levofolinate? Clinical trials are investigating Disodium Levofolinate for various types of cancer, including metastatic esophageal cancer, colon cancer (stage II and III), and metastatic pancreatic ductal adenocarcinoma.
  • How is Disodium Levofolinate administered? Disodium Levofolinate is typically administered through intravenous infusion. The dosage and frequency may vary depending on the specific trial and treatment regimen.
  • What are the potential benefits of using Disodium Levofolinate in cancer treatment? Researchers are studying whether Disodium Levofolinate, when used in combination with other chemotherapy drugs, can improve treatment outcomes such as overall survival, progression-free survival, and response rates in cancer patients.
  • Are there any side effects associated with Disodium Levofolinate? While specific side effects are not mentioned in the provided trial information, patients in these studies are closely monitored for adverse events. As with any medication, potential side effects would be discussed with patients before starting treatment.

Ongoing Clinical Trials on Disodium Levofolinate

  • Study on Colon Cancer Treatment Using Disodium Levofolinate and Drug Combination for Patients with Operable Stage III and High-Risk Stage II Colon Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy Spain

Glossary

  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Esophageal Carcinoma: Cancer that develops in the esophagus, the tube that connects the throat to the stomach.
  • Pancreatic Ductal Adenocarcinoma: The most common type of pancreatic cancer, which starts in the ducts of the pancreas.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • ctDNA: Circulating tumor DNA, which are small pieces of DNA from cancer cells found in the blood.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Adjuvant Therapy: Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or level of treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-pembrolizumab-lenvatinib-and-chemotherapy-for-patients-with-metastatic-esophageal-cancer/
  2. http://clinicaltrials.eu/trial/study-on-colon-cancer-treatment-using-disodium-levofolinate-and-drug-combination-for-patients-with-operable-stage-iii-and-high-risk-stage-ii-colon-cancer/
  3. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-mitazalimab-with-chemotherapy-for-patients-with-metastatic-pancreatic-cancer/