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Calcium Folinate Pentahydrate

Calcium Folinate Pentahydrate, also known as leucovorin, is being studied in several clinical trials for its potential to enhance the effectiveness of chemotherapy in treating various types of cancer. This article explores the use of Calcium Folinate Pentahydrate in combination with other drugs for treating pancreatic, colorectal, gastric, and esophageal cancers. The trials aim to evaluate the safety and efficacy of these combination therapies in improving patient outcomes.

Table of Contents

What is Calcium Folinate Pentahydrate?

Calcium folinate pentahydrate is a medication used in cancer treatment. It is also known by other names such as leucovorin calcium or simply calcium folinate.[1] This drug is a form of folic acid that can help protect healthy cells from the harmful effects of certain chemotherapy drugs while enhancing their effectiveness against cancer cells.

Medical Uses

Calcium folinate pentahydrate is primarily used in combination with other medications for the treatment of various types of cancer, including:

  • Colorectal cancer: It is often used as part of chemotherapy regimens for both early-stage and metastatic colorectal cancer.[2]
  • Gastric (stomach) cancer: It is included in treatment protocols for advanced or metastatic gastric cancer.[3]
  • Esophageal cancer: It is used in combination therapies for esophageal adenocarcinoma.[4]
  • Pancreatic cancer: It is part of chemotherapy regimens for resected pancreatic cancer.[1]

The medication works by enhancing the effects of fluorouracil (5-FU), a common chemotherapy drug. It can also help reduce the toxic effects of certain other chemotherapy medications on healthy cells.

How it is Administered

Calcium folinate pentahydrate is typically administered intravenously (through a vein) in a hospital or clinic setting. It is usually given as part of a combination chemotherapy regimen, often alongside drugs like fluorouracil, oxaliplatin, or irinotecan.[5]

Dosage

The dosage of calcium folinate pentahydrate can vary depending on the specific cancer type, treatment regimen, and individual patient factors. Some common dosages observed in clinical trials include:

  • 200-400 mg/m² (milligrams per square meter of body surface area) per day[5]
  • Up to 400 mg/kg (milligrams per kilogram of body weight) in some regimens[3]

It’s important to note that dosages should always be determined by a healthcare professional based on the individual patient’s needs and treatment plan.

Potential Side Effects

While calcium folinate pentahydrate is generally well-tolerated, it may cause some side effects. These can include:

  • Nausea and vomiting
  • Diarrhea
  • Fatigue
  • Mouth sores
  • Allergic reactions (rare)

It’s important to report any side effects to your healthcare provider, as they can often be managed effectively.

Precautions and Contraindications

There are certain situations where calcium folinate pentahydrate should be used with caution or avoided:

  • Pernicious anemia: Calcium folinate is contraindicated in patients with pernicious anemia or other anemias due to vitamin B12 deficiency.[6]
  • Pregnancy and breastfeeding: The safety of this medication during pregnancy and breastfeeding has not been fully established. Patients should discuss the risks and benefits with their healthcare provider.
  • Allergies: Patients with known hypersensitivity to calcium folinate or any of its components should not use this medication.
  • DPD deficiency: Patients with dihydropyrimidine dehydrogenase (DPD) deficiency may require dose adjustments or alternative treatments.[6]

Ongoing Research

Calcium folinate pentahydrate continues to be studied in various clinical trials, often as part of combination therapies for different types of cancer. Some areas of ongoing research include:

  • Its use in immunotherapy combinations for gastric and esophageal cancers[6]
  • Optimizing dosing schedules to improve efficacy and reduce side effects
  • Its potential role in organ-preserving strategies for early-stage esophageal cancer[4]

These studies aim to further improve treatment outcomes and quality of life for cancer patients.

Cancer Type Trial Combination Primary Endpoints Key Inclusion Criteria
Pancreatic Cancer Autogene Cevumeran + Atezolizumab + mFOLFIRINOX vs. mFOLFIRINOX alone Disease-free survival (DFS) Resected pancreatic ductal adenocarcinoma
Gastric/Gastroesophageal Cancer Ramucirumab + FOLFIRI vs. Ramucirumab + Paclitaxel Overall survival (OS), Objective response rate (ORR) Advanced/metastatic adenocarcinoma, failed prior chemotherapy
Esophageal Adenocarcinoma Durvalumab + Chemoradiation Clinical/pathological complete response rate Early-stage (T1-T2N0) esophageal adenocarcinoma
Gastric/Esophagogastric Junction Cancer Atezolizumab + FLOT vs. FLOT alone Event-free survival (EFS) Locally advanced, resectable adenocarcinoma

FAQ

  • What is Calcium Folinate Pentahydrate? Calcium Folinate Pentahydrate, also known as leucovorin, is a medication used in combination with chemotherapy drugs to enhance their effectiveness in treating various types of cancer.
  • Which types of cancer are being studied with Calcium Folinate Pentahydrate? The clinical trials are investigating the use of Calcium Folinate Pentahydrate in combination therapies for pancreatic cancer, colorectal cancer, gastric cancer, and esophageal cancer.
  • How is Calcium Folinate Pentahydrate administered? Calcium Folinate Pentahydrate is typically administered as an intravenous infusion or injection in combination with other chemotherapy drugs.
  • What are the potential benefits of using Calcium Folinate Pentahydrate in cancer treatment? The potential benefits include improved efficacy of chemotherapy drugs, better tumor response rates, and potentially improved survival outcomes for patients with various types of cancer.
  • Are there any specific side effects associated with Calcium Folinate Pentahydrate? While specific side effects of Calcium Folinate Pentahydrate are not mentioned in the trial data, patients are closely monitored for adverse events related to the combination therapies. It's important to note that side effects can vary depending on the individual and the specific treatment regimen.

Ongoing Clinical Trials on Calcium Folinate Pentahydrate

  • A study of futibatinib combined with tislelizumab, fluorouracil, calcium folinate, and oxaliplatin as first-line treatment for patients with colorectal cancer

    Recruiting

    2 1 1 1
    Investigated drugs:
    Germany

  • Study on Recurrent Colorectal Liver Metastases: Evaluating Calcium Folinate, Fluorouracil, Capecitabine, Oxaliplatin, and Irinotecan in a Drug Combination for Eligible Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • 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 the Safety and Effectiveness of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2+ Resectable Esophagogastric Cancer

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

  • Study on Atezolizumab with FOLFOX for Stage III Colon Cancer with Deficient DNA Mismatch Repair

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study Comparing Short-Course and Long-Course Chemotherapy with mFOLFIRINOX or PAXG for Patients with Stage I-III Pancreatic Cancer

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Organ Preservation for Early Stage Esophageal Cancer Using Durvalumab and Chemoradiation for Patients Eligible for Surgery

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Atezolizumab with Drug Combination for Patients with Gastric Cancer and Esophagogastric Junction Adenocarcinoma

    Not recruiting

    4 1 1 1
    Investigated drugs:
    Germany

  • Study Comparing Short Course Radiotherapy and Chemoradiotherapy with Fluorouracil, Calcium Folinate, and Capecitabine for Intermediate and High-Risk Rectal Cancer Patients

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study Comparing Ramucirumab with Irinotecan, Leucovorin, and 5-FU or Paclitaxel for Patients with Advanced Stomach or Gastroesophageal Cancer After Previous Chemotherapy

    Not recruiting

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

Glossary

  • Adenocarcinoma: A type of cancer that begins in glandular cells, which are found in various tissues throughout the body, including the digestive system.
  • Atezolizumab: An immunotherapy drug that helps the immune system fight cancer cells.
  • CTCAE: Common Terminology Criteria for Adverse Events, a standardized system for classifying the severity of side effects in cancer therapy.
  • DPD deficiency: Dihydropyrimidine dehydrogenase deficiency, a genetic condition that affects the body's ability to break down certain chemotherapy drugs.
  • Event-free survival (EFS): The length of time after treatment during which no specified events (such as disease progression, relapse, or death) occur.
  • FOLFIRI: A chemotherapy regimen that combines folinic acid (leucovorin), fluorouracil, and irinotecan.
  • FOLFOX: A chemotherapy regimen that combines folinic acid (leucovorin), fluorouracil, and oxaliplatin.
  • Gastroesophageal junction (GEJ): The area where the esophagus meets the stomach.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • mFOLFIRINOX: A modified version of the FOLFIRINOX chemotherapy regimen, which includes fluorouracil, leucovorin, irinotecan, and oxaliplatin.
  • Neoadjuvant therapy: Treatment given before the main treatment, usually to shrink a tumor before surgery.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • PD-L1: Programmed death-ligand 1, a protein that plays a role in suppressing the immune response.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • R0 resection: Complete removal of a tumor with no cancer cells at the edges of the removed tissue.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-autogene-cevumeran-atezolizumab-and-mfolfirinox-in-patients-with-resected-pancreatic-cancer/
  2. http://clinicaltrials.eu/trial/study-on-chemotherapy-with-irinotecan-fluorouracil-and-oxaliplatin-for-patients-with-metastatic-colorectal-cancer-after-surgery-or-ablation/
  3. http://clinicaltrials.eu/trial/study-comparing-ramucirumab-with-irinotecan-leucovorin-and-5-fu-or-paclitaxel-for-patients-with-advanced-stomach-or-gastroesophageal-cancer-after-previous-chemotherapy/
  4. http://clinicaltrials.eu/trial/study-on-organ-preservation-for-early-stage-esophageal-cancer-using-durvalumab-and-chemoradiation-for-patients-eligible-for-surgery/
  5. http://clinicaltrials.eu/trial/study-comparing-short-course-radiotherapy-and-chemoradiotherapy-with-fluorouracil-calcium-folinate-and-capecitabine-for-intermediate-and-high-risk-rectal-cancer-patients/
  6. http://clinicaltrials.eu/trial/study-on-atezolizumab-with-drug-combination-for-patients-with-gastric-cancer-and-esophagogastric-junction-adenocarcinoma/