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Disodium Folinate

Disodium folinate, also known as sodium folinate or leucovorin calcium, is being studied in several clinical trials for its potential role in cancer treatment, particularly in combination with other chemotherapy drugs. This article explores the use of disodium folinate in ongoing clinical trials for various types of cancer, including colorectal, esophagogastric, and other advanced cancers.

Table of Contents

What is Disodium Folinate?

Disodium folinate, also known as sodium folinate or leucovorin, is a medication used in cancer treatment and to counteract the toxic effects of certain chemotherapy drugs[1]. It is a form of folic acid that can be easily used by the body. Disodium folinate is typically administered as a solution for injection or infusion[2].

Medical Uses

Disodium folinate is primarily used in the treatment of colorectal cancer, often in combination with other chemotherapy drugs. It has several important applications:

  • Enhancing the effectiveness of chemotherapy drugs like fluorouracil (5-FU)
  • Reducing the toxic side effects of certain chemotherapy medications
  • Treating folate deficiency in some patients
  • As part of combination therapies for advanced colorectal cancer[3]

How It Works

Disodium folinate works by providing an active form of folic acid to cells. In cancer treatment, it helps to:

  • Enhance the effect of fluorouracil (5-FU) on cancer cells
  • Protect healthy cells from the toxic effects of certain chemotherapy drugs
  • Support the body’s production of healthy blood cells[4]

Administration

Disodium folinate is typically administered intravenously (through a vein) in a hospital or clinic setting. It is often given as part of a chemotherapy regimen, such as FOLFIRI (a combination of folinic acid, fluorouracil, and irinotecan) or FOLFOX (folinic acid, fluorouracil, and oxaliplatin)[5].

Dosage

The dosage of disodium folinate can vary depending on the specific treatment regimen and the patient’s individual needs. In clinical trials, doses have ranged from 200 to 500 mg/m² (milligrams per square meter of body surface area)[2][5]. However, the exact dosage should always be determined by a healthcare professional.

Side Effects

While disodium folinate is generally well-tolerated, some patients may experience side effects. Common side effects may include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Fatigue
  • Mouth sores

It’s important to note that many side effects experienced during treatment may be due to the chemotherapy drugs used in combination with disodium folinate, rather than disodium folinate itself[6].

Precautions

Patients should inform their healthcare provider about any allergies, medical conditions, or medications they are taking before starting treatment with disodium folinate. Special precautions may be necessary for patients with:

  • Kidney problems
  • Liver disease
  • History of seizures
  • Pregnancy or breastfeeding

Additionally, patients with a known deficiency of an enzyme called dihydropyrimidine dehydrogenase (DPD) may require dose adjustments or alternative treatments[5].

Ongoing Research

Disodium folinate continues to be studied in various clinical trials, particularly in combination with other cancer treatments. Current research is exploring its use in:

  • Improving outcomes for patients with metastatic colorectal cancer[3]
  • Enhancing the effectiveness of chemotherapy regimens like FOLFIRI and FOLFOX[5]
  • Investigating its role in perioperative treatment (treatment before and after surgery) for localized gastroesophageal cancer[4]

These ongoing studies aim to optimize treatment strategies and improve patient outcomes in various types of cancer, particularly colorectal and gastroesophageal cancers.

Trial Name Cancer Type Treatment Combination Primary Endpoints
PROTECTOR/FIRE-10 HER2-positive localized esophagogastric adenocarcinoma Disodium folinate with pembrolizumab, trastuzumab, and FLOT Disease-free survival and pathological complete response rate
FIRE-9 – PORT Metastatic colorectal cancer Disodium folinate as part of post-resection/ablation chemotherapy Progression-free survival at 24 months
SCO-101 with FOLFIRI Metastatic colorectal cancer resistant to FOLFIRI Disodium folinate as part of FOLFIRI regimen with SCO-101 Safety, tolerability, maximum tolerated dose, and objective response rate
Nivolumab combination study Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient Metastatic Colorectal Cancer Disodium folinate as part of chemotherapy regimen Progression-free survival by blinded independent central review
Pan Tumor Roll Over Study Various advanced cancers Disodium folinate as part of long-term treatment regimens Long-term safety and efficacy of nivolumab alone or in combination therapies

FAQ

  • What is disodium folinate? Disodium folinate is a form of folic acid used in cancer treatment. It's often given alongside chemotherapy drugs to enhance their effectiveness and reduce side effects.
  • In which types of cancer is disodium folinate being studied? Disodium folinate is being studied in clinical trials for various cancers, including metastatic colorectal cancer, esophagogastric cancer, and other advanced solid tumors.
  • How is disodium folinate administered in these trials? In the clinical trials, disodium folinate is typically administered intravenously as part of combination chemotherapy regimens, such as FOLFIRI or FLOT.
  • What are the potential benefits of using disodium folinate in cancer treatment? Disodium folinate may enhance the effectiveness of certain chemotherapy drugs, potentially improving treatment outcomes and survival rates for cancer patients.
  • Are there any specific side effects associated with disodium folinate? While specific side effects of disodium folinate alone are not mentioned in the trial data, patients should be aware that it's used in combination with other chemotherapy drugs which may have their own side effects.

Ongoing Clinical Trials on Disodium Folinate

  • Study on Pre-Operative Chemotherapy with Disodium Folinate, Oxaliplatin, and Fluorouracil for Patients with Advanced Resectable Colon Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Chemotherapy with Irinotecan, Fluorouracil, and Oxaliplatin for Patients with Metastatic Colorectal Cancer After Surgery or Ablation

    Recruiting

    3 1 1 1
    Investigated drugs:
    Germany

  • Study on Long-term Safety of Nivolumab and Drug Combination for Cancer Patients from Previous BMS Trials

    Recruiting

    2 1 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +4

  • Study of SCO-101 with FOLFIRI for Patients with Metastatic Colorectal Cancer Resistant to FOLFIRI

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Spain

  • Study Comparing Nivolumab, Nivolumab with Ipilimumab, or Chemotherapy for Patients with Metastatic Colorectal Cancer with High Microsatellite Instability

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +6

  • Study of Pembrolizumab, Trastuzumab, and Drug Combination for Patients with HER2-Positive, Localized Esophagogastric Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Disodium Folinate: A form of folic acid used in cancer treatment, often in combination with chemotherapy drugs to enhance their effectiveness and reduce side effects.
  • FOLFIRI: A chemotherapy regimen that includes folinic acid (leucovorin), fluorouracil, and irinotecan, commonly used in colorectal cancer treatment.
  • FLOT: A chemotherapy regimen consisting of fluorouracil, leucovorin, oxaliplatin, and docetaxel, used in the treatment of gastric and esophagogastric cancers.
  • Metastatic Colorectal Cancer (mCRC): Colorectal cancer that has spread from the colon or rectum to other parts of the body.
  • HER2-positive: Refers to cancer cells that have a protein called human epidermal growth factor receptor 2 (HER2) on their surface, which promotes cancer cell growth.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to assess how well a cancer patient responds to treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.

References

  1. http://clinicaltrials.eu/trial/study-comparing-nivolumab-nivolumab-with-ipilimumab-or-chemotherapy-for-patients-with-metastatic-colorectal-cancer-with-high-microsatellite-instability/
  2. http://clinicaltrials.eu/trial/study-on-pre-operative-chemotherapy-with-disodium-folinate-oxaliplatin-and-fluorouracil-for-patients-with-advanced-resectable-colon-cancer/
  3. http://clinicaltrials.eu/trial/study-on-long-term-safety-of-nivolumab-and-drug-combination-for-cancer-patients-from-previous-bms-trials/
  4. http://clinicaltrials.eu/trial/study-of-pembrolizumab-trastuzumab-and-drug-combination-for-patients-with-her2-positive-localized-esophagogastric-cancer/
  5. http://clinicaltrials.eu/trial/study-on-chemotherapy-with-irinotecan-fluorouracil-and-oxaliplatin-for-patients-with-metastatic-colorectal-cancer-after-surgery-or-ablation/
  6. http://clinicaltrials.eu/trial/study-of-sco-101-with-folfiri-for-patients-with-metastatic-colorectal-cancer-resistant-to-folfiri/