#1 Clinical Trials Search in Europe

Doxorubicin Hydrochloride

Doxorubicin Hydrochloride, a powerful chemotherapy drug, is being extensively studied in clinical trials for various types of cancer. These trials aim to evaluate its effectiveness, safety, and potential new applications when used alone or in combination with other treatments. The research spans different formulations and dosing regimens, seeking to optimize patient outcomes while minimizing side effects.

Table of Contents

What is Doxorubicin Hydrochloride?

Doxorubicin Hydrochloride, commonly known as doxorubicin, is a powerful chemotherapy drug used to treat various types of cancer. It belongs to a class of medications called anthracyclines. Doxorubicin is also known by several other names, including Adriamycin, hydroxydaunorubicin, and Rubex[1]. These alternative names are important to know as your healthcare provider might use them interchangeably.

How Does Doxorubicin Work?

Doxorubicin works by interfering with the growth and spread of cancer cells in your body. It does this in several ways:

  • It stops cancer cells from dividing and growing
  • It damages the DNA in cancer cells, which can lead to cell death
  • It may also affect the formation of new blood vessels that tumors need to grow
By targeting rapidly dividing cells, doxorubicin can effectively slow down or stop the growth of tumors[2].

What Conditions Does Doxorubicin Treat?

Doxorubicin is used to treat a wide range of cancers. Based on the clinical trials information provided, it has been studied for use in:

  • Soft Tissue Sarcoma: A type of cancer that develops in soft tissues like muscles, tendons, and blood vessels[3]
  • Ovarian Cancer: Cancer that begins in the ovaries[4]
  • Kidney Cancer: Including advanced or metastatic renal cell carcinoma[1]
  • Urothelial Cancer: Cancer that affects the urinary system, including the bladder[5]
  • Breast Cancer: Particularly in cases of triple-negative breast cancer[6]
  • Prostate Cancer: Especially in cases that don’t respond to hormone therapy[7]
It’s important to note that doxorubicin may be used for other types of cancer as well, depending on your specific diagnosis and treatment plan.

How is Doxorubicin Administered?

Doxorubicin is typically given as an intravenous (IV) injection or infusion. This means it’s delivered directly into your bloodstream through a vein. The dosage and frequency of administration can vary depending on several factors, including:

  • The type and stage of cancer being treated
  • Your body size (often calculated as body surface area)
  • Your overall health and how well you tolerate the medication
In some of the clinical trials, doxorubicin was administered in the following ways:
  • 75 mg/m² IV on day 1 of each 21-day cycle[3]
  • 24 mg/m² IV weekly for 12 weeks[6]
Your healthcare team will determine the most appropriate dosing schedule for your specific situation[3][6].

Doxorubicin in Combination Therapy

Doxorubicin is often used in combination with other cancer treatments to enhance its effectiveness. Some combinations being studied include:

  • Doxorubicin + L19TNF: For advanced soft tissue sarcoma[3]
  • Doxorubicin + Ixazomib + Gemcitabine: For kidney cancer and urothelial cancer[1][5]
  • Doxorubicin + Pembrolizumab: For advanced sarcomas[2]
  • Doxorubicin + Tazemetostat: For advanced epithelioid sarcoma[8]
  • Doxorubicin + Cyclophosphamide + Paclitaxel + Carboplatin: For breast cancer[6]
  • Doxorubicin + Estramustine: For prostate cancer[7]
These combinations are designed to target cancer cells in multiple ways, potentially improving treatment outcomes.

Potential Side Effects

Like all chemotherapy drugs, doxorubicin can cause side effects. Common side effects may include:

  • Nausea and vomiting
  • Hair loss
  • Fatigue
  • Increased risk of infections
  • Mouth sores
One important potential side effect to be aware of is heart damage. Doxorubicin can affect heart function, especially at higher cumulative doses. Your doctor will monitor your heart health closely during treatment[3]. It’s crucial to report any side effects you experience to your healthcare team. They can help manage these effects and may adjust your treatment if necessary.

Ongoing Research and Clinical Trials

Researchers are continually studying doxorubicin to find new ways to use it more effectively and safely. Some areas of ongoing research include:

  • New drug combinations: Combining doxorubicin with newer drugs like pembrolizumab (an immunotherapy drug) or tazemetostat (a targeted therapy)[2][8]
  • Different dosing schedules: Such as “metronomic” dosing, which involves giving smaller doses more frequently[6]
  • Use in specific cancer types: For example, studying its effectiveness in triple-negative breast cancer or advanced epithelioid sarcoma[6][8]
These ongoing studies aim to improve treatment outcomes and reduce side effects for patients receiving doxorubicin.

Aspect Details
Cancer Types Studied Ovarian, breast, soft tissue sarcoma, epithelioid sarcoma, AIDS-related Kaposi sarcoma, multiple myeloma
Administration Methods Intravenous infusion, often as liposomal formulation
Common Dosages 50 mg/m2 every 28 days, 75 mg/m2 on day 1 of each cycle (up to 6 cycles)
Primary Objectives Safety assessment, efficacy evaluation, pharmacokinetic analysis, bioequivalence studies
Combination Therapies With bevacizumab, tazemetostat, and other anticancer agents
Key Outcome Measures Progression-free survival, overall survival, response rates, adverse events
Specific Monitoring Cardiotoxicity, left ventricular ejection fraction, hematological toxicities
Trial Durations Typically several months to over a year, with long-term follow-up

FAQ

  • What types of cancer are being studied with Doxorubicin Hydrochloride in clinical trials? Clinical trials are investigating Doxorubicin Hydrochloride for various cancers, including ovarian cancer, breast cancer, soft tissue sarcoma, epithelioid sarcoma, and AIDS-related Kaposi sarcoma. Some trials also focus on multiple myeloma and other advanced solid tumors.
  • How is Doxorubicin Hydrochloride administered in these trials? Doxorubicin Hydrochloride is typically administered intravenously (IV). The dosage and frequency vary between trials, but common regimens include 50 mg/m2 every 28 days or 75 mg/m2 on day 1 of each cycle for up to 6 cycles. Some trials use liposomal formulations for potentially improved delivery.
  • What are the main goals of these clinical trials? The primary goals include assessing the drug's safety, tolerability, and efficacy. Researchers are also studying its pharmacokinetics, bioequivalence of different formulations, and its effectiveness when combined with other treatments like bevacizumab or tazemetostat.
  • Are there any specific side effects being monitored in these trials? Yes, researchers are closely monitoring for various side effects, including cardiotoxicity. Some trials specifically assess left ventricular ejection fraction and use cardiac MRI for screening. Other common side effects being tracked include hematological toxicities and general adverse events.
  • How long do these clinical trials typically last? The duration of trials varies, but many last for several months to a year or more. Some studies follow patients for extended periods, often up to two years after treatment, to assess long-term outcomes and survival rates.

Ongoing Clinical Trials on Doxorubicin Hydrochloride

  • Study on the Effects of Durvalumab, Oleclumab, and Chemotherapy in Patients with Luminal B Breast Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

  • Study on Imatinib and Chemotherapy Combination for Children with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +6

  • Study of Bintrafusp Alfa and Doxorubicin Hydrochloride for Adults with Advanced Soft-Tissue Sarcoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Acute Lymphoblastic Leukemia Treatment in Children and Adolescents Using Bortezomib, Blinatumomab, and Methotrexate Combination

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Poland

Glossary

  • Doxorubicin Hydrochloride: A chemotherapy drug used to treat various types of cancer. It works by interfering with the growth and spread of cancer cells in the body.
  • Liposomal: A drug delivery method where the medication is encapsulated in tiny fat bubbles, potentially improving its distribution in the body and reducing side effects.
  • Bioequivalence: The property of two drug products having the same active ingredient, dosage form, strength, and route of administration, showing comparable safety and effectiveness.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Cardiotoxicity: The occurrence of heart muscle damage or impaired heart function as a side effect of certain medications, particularly some cancer treatments.
  • Left Ventricular Ejection Fraction (LVEF): A measurement of how much blood the left ventricle pumps out with each contraction, used to assess heart function.
  • Progression-free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment that patients are still alive.
  • Response Evaluation Criteria in Solid Tumors (RECIST): A set of rules used to assess how well a cancer patient responds to treatment, based on changes in tumor size.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure.

References

  1. https://clinicaltrials.gov/study/NCT03587662
  2. https://clinicaltrials.gov/study/NCT02888665
  3. https://clinicaltrials.gov/study/NCT04032964
  4. https://clinicaltrials.gov/study/NCT01715168
  5. https://clinicaltrials.gov/study/NCT02420847
  6. https://clinicaltrials.gov/study/NCT00542191
  7. https://clinicaltrials.gov/study/NCT00002721
  8. https://clinicaltrials.gov/study/NCT04204941