Irinotecan Hydrochloride Trihydrate

This article explores the use of Irinotecan Hydrochloride Trihydrate in clinical trials for treating esophageal cancer. The drug is being studied as part of a combination therapy that includes chemotherapy, radiation, and surgery. This approach aims to improve outcomes for patients with potentially resectable thoracic esophageal cancer by shrinking tumors before surgery and potentially increasing survival rates.

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan Hydrochloride Trihydrate, often simply referred to as Irinotecan, is a powerful chemotherapy drug used in the treatment of various cancers. In this clinical trial, it is being studied specifically for its effectiveness against esophageal cancer, a serious form of cancer that affects the tube connecting the throat to the stomach[1].

Treatment Approach for Esophageal Cancer

The clinical trial is exploring a comprehensive treatment approach for potentially resectable thoracic esophageal cancer. This means the cancer is located in the chest area of the esophagus and may be removable through surgery. The treatment plan includes:

  1. Pre-operative chemotherapy: This involves giving chemotherapy drugs before surgery to shrink the tumor.
  2. Radiotherapy: This includes both external beam radiation and brachytherapy (a type of internal radiation).
  3. Surgery: After the chemotherapy and radiation, surgery is performed to remove the remaining cancer[1].

This combination approach aims to improve the chances of successfully treating esophageal cancer compared to using surgery alone.

How Irinotecan Works

Irinotecan is used in combination with another chemotherapy drug called Cisplatin. Together, these drugs are expected to be more effective in treating esophageal cancer than older drug combinations. Here’s how they work:

  • Targeting cancer cells: Both Irinotecan and Cisplatin are designed to attack and kill cancer cells.
  • Radiosensitizing properties: These drugs make cancer cells more sensitive to radiation therapy, potentially improving its effectiveness[1].
  • Controlling metastasis: The drug combination is hoped to better control the spread of cancer to other parts of the body (metastasis).

Dosage and Administration

In this clinical trial, Irinotecan is administered as follows:

  • Dosage: 65mg/m² (milligrams per square meter of body surface area)
  • Schedule: Given during weeks 1-2, 4-5, and 7-8 of the treatment cycle[1]

This dosage and schedule are designed to maximize the drug’s effectiveness while managing potential side effects.

Expected Outcomes and Measures

The clinical trial is looking at several important outcomes to determine how well Irinotecan works for esophageal cancer:

  • Pathological complete response: This is the main outcome being measured. It refers to the absence of any detectable cancer cells after treatment[1].
  • Disease-free survival: How long patients live without any signs of cancer returning.
  • Overall survival: How long patients live after starting treatment.
  • Quality of life: Measured using a specific questionnaire called FACT-E.
  • Clinical complete response rate: How many patients show no signs of cancer after treatment, based on medical examinations and scans.

Potential Side Effects

While the specific side effects of Irinotecan in this trial are not detailed, the study is monitoring for both acute (short-term) and late (long-term) toxicities[1]. Common side effects of chemotherapy drugs like Irinotecan may include:

  • Nausea and vomiting
  • Fatigue
  • Hair loss
  • Increased risk of infections

It’s important to note that not everyone experiences the same side effects, and your healthcare team will work to manage any that do occur.

Aspect Details
Study Type Phase II clinical trial
Condition Resectable thoracic esophageal cancer
Treatment Approach Pre-operative chemotherapy, radiotherapy, and surgery
Drugs Used Irinotecan Hydrochloride Trihydrate and Cisplatin
Irinotecan Dosage 65mg/m2 during weeks 1-2, 4-5, and 7-8
Cisplatin Dosage 30 mg/m2 during weeks 1-2, 4-5, and 7-8
Primary Outcome Pathological complete response
Secondary Outcomes Toxicities, postoperative mortality, survival rates, quality of life, tumor characteristics

Ongoing Clinical Trials on Irinotecan Hydrochloride Trihydrate

  • Study on Irinotecan and mFOLFOX4-Bevacizumab for Patients with Resectable Colorectal Peritoneal Metastases

    Not yet recruiting

    2 1 1 1
    The Netherlands
  • Study of Tarlatamab alone or with FOLFIRI chemotherapy for patients with advanced digestive system or unknown origin neuroendocrine carcinomas

    Not recruiting

    2 1 1 1
    Investigated diseases:
    France Spain
  • Study on Chemotherapy with Irinotecan, Folinic Acid, Fluorouracil, Oxaliplatin, and Floxuridine for Patients with Colorectal Cancer Spread to the Liver

    Not recruiting

    4 1 1 1
    Investigated diseases:
    The Netherlands
  • Study on the Effectiveness and Safety of AZD0901 Compared to Standard Treatments for Adults with Advanced Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2

    Not recruiting

    3 1 1 1
    France Germany Italy Poland Spain
  • Study on Dostarlimab, Vitamin D3, and Drug Combination for Untreated Metastatic Pancreatic Cancer Patients

    Not recruiting

    2 1 1 1
    France
  • Study of Palbociclib with Drug Combinations for Children and Young Adults with Recurrent or Refractory Neuroblastoma and Ewing Sarcoma

    Not recruiting

    1 1 1 1
    Czechia France Germany Slovakia Sweden
  • Study on Sonoporation-Enhanced Treatment with Gemcitabine, Nab-Paclitaxel, and FOLFIRINOX for Patients with Inoperable Pancreatic Cancer

    Not recruiting

    2 1 1 1
    Norway
  • 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
    Austria Germany Italy
  • Study on Napabucasin with FOLFIRI for Adults with Metastatic Colorectal Cancer After Standard Treatments

    Not recruiting

    3 1 1 1
    France Spain
  • Study of Futibatinib with Pembrolizumab and Chemotherapy for Patients with Solid Tumors

    Not recruiting

    2 1 1 1
    France Germany Spain

Glossary

  • Esophageal Cancer: A type of cancer that develops in the esophagus, the tube that connects the throat to the stomach.
  • Irinotecan Hydrochloride Trihydrate: A chemotherapy drug used in this trial to treat esophageal cancer, given in combination with other treatments.
  • Cisplatin: Another chemotherapy drug used in combination with Irinotecan in this trial.
  • Radiotherapy: The use of radiation to kill cancer cells, including external beam radiation and brachytherapy in this trial.
  • Brachytherapy: A type of internal radiation therapy where a radiation source is placed inside or near the area requiring treatment.
  • Resectable: Referring to a tumor that can be surgically removed.
  • Induction therapy: Initial treatment given to shrink a tumor before the main treatment, usually surgery.
  • Pathological complete response: When no cancer cells are found in tissue samples after treatment.
  • Disease-free survival: The length of time after treatment during which no disease is found.
  • Quality of life (FACT-E): A measure of a patient's well-being, specifically using the Functional Assessment of Cancer Therapy-Esophageal questionnaire.
  • Microvessel density: A measure of the number of blood vessels in a tumor, which can indicate how well it's supplied with blood.
  • Perfusion CT: A type of CT scan that measures blood flow in tissues.
  • PET scan: Positron Emission Tomography, an imaging test that helps detect cancer and assess the effectiveness of treatment.

References

  1. https://clinicaltrials.gov/study/NCT00160875