CLINICAL TRIALS PROFILE FOR ETOPOSIDE PHOSPHATE

All Clinical Trials for Etoposide Phosphate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002880 ↗	Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1996-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients with relapsed non-Hodgkin's lymphoma.
NCT00002880 ↗	Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma	Completed	Alliance for Clinical Trials in Oncology	Phase 2	1996-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients with relapsed non-Hodgkin's lymphoma.
NCT00002961 ↗	Chemotherapy With or Without Total-Body Irradiation Prior to Bone Marrow Transplantation in Treating Children With Acute Lymphoblastic Leukemia	Terminated	Children's Hospital of Philadelphia	Phase 3	1995-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy, radiation therapy, and bone marrow transplantation may kill more cancer cells. PURPOSE: Randomized phase III trial to compare high-dose chemotherapy with or without total-body irradiation before bone marrow transplantation in treating children with acute lymphoblastic leukemia.
NCT00003064 ↗	Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer	Unknown status	National Cancer Institute (NCI)	Phase 1/Phase 2	1997-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and autologous peripheral stem cell transplantation in treating patients with recurrent or persistent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.
NCT00003064 ↗	Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer	Unknown status	Herbert Irving Comprehensive Cancer Center	Phase 1/Phase 2	1997-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and autologous peripheral stem cell transplantation in treating patients with recurrent or persistent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.
NCT00005792 ↗	Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma	Completed	Bristol-Myers Squibb	Phase 1	1998-06-02	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have multiple myeloma.
NCT00005792 ↗	Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma	Completed	SmithKline Beecham	Phase 1	1998-06-02	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have multiple myeloma.

Clinical Trial Conditions for Etoposide Phosphate

Condition Name

Condition Name for Etoposide Phosphate
Intervention	Trials
Lymphoma	17
Leukemia	10
Neuroblastoma	7
Brain and Central Nervous System Tumors	6

Condition MeSH

Condition MeSH for Etoposide Phosphate
Intervention	Trials
Lymphoma	41
Leukemia	27
Leukemia, Lymphoid	15
Hodgkin Disease	13

Clinical Trial Locations for Etoposide Phosphate

Trials by Country

Trials by Country for Etoposide Phosphate
Location	Trials
United States	726
Canada	62
United Kingdom	28
Australia	26
Germany	12

Trials by US State

Trials by US State for Etoposide Phosphate
Location	Trials
California	35
Texas	30
Ohio	27
Pennsylvania	25
Michigan	22

Clinical Trial Progress for Etoposide Phosphate

Clinical Trial Phase

Clinical Trial Phase for Etoposide Phosphate
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	23
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Etoposide Phosphate
Clinical Trial Phase	Trials
Completed	34
Recruiting	21
Active, not recruiting	17

Clinical Trial Sponsors for Etoposide Phosphate

Sponsor Name

Sponsor Name for Etoposide Phosphate
Sponsor	Trials
National Cancer Institute (NCI)	46
Children's Oncology Group	8
City of Hope Medical Center	7

Sponsor Type

Sponsor Type for Etoposide Phosphate
Sponsor	Trials
Other	101
NIH	46
Industry	27

Etoposide Phosphate: Clinical Trials, Market Analysis, and Projections

Introduction

Etoposide phosphate, a semisynthetic derivative of podophyllotoxin, is a crucial chemotherapy agent used primarily in the treatment of small cell lung cancer (SCLC) and other malignancies. This article delves into the current clinical trials, market analysis, and future projections for etoposide phosphate.

Clinical Trials Update

Ongoing Studies

One significant ongoing clinical trial involves the comparison of serplulimab plus chemotherapy (carboplatin-etoposide) with atezolizumab plus chemotherapy in patients with extensive stage small cell lung cancer (ES-SCLC). This Phase 3 study, conducted at the University of California Health, aims to evaluate the efficacy and safety of these treatment regimens. Participants are randomized to either receive serplulimab or atezolizumab in combination with carboplatin and etoposide[1].

Previous Studies

Previous clinical studies have established the efficacy and safety profile of etoposide phosphate. A Phase II trial compared etoposide phosphate plus cisplatin with etoposide plus cisplatin in patients with SCLC, showing equivalent response rates and toxicity profiles between the two treatment arms. This study highlighted that etoposide phosphate is easier to administer and preferable for routine clinical use due to its ease of administration and comparable efficacy[3].

Mechanism of Action

Etoposide phosphate acts by inhibiting DNA topoisomerase II, which is crucial for DNA replication and cell division. This inhibition prevents DNA re-ligation, leading to DNA strand breaks and ultimately causing apoptotic death in cancer cells. The drug is most effective during the S and G2 phases of the cell cycle[2][5].

Market Analysis

Global Market Trends

The global etoposide market is expected to grow significantly during the forecast period (2021-2027), driven by the rising prevalence of lung cancer, Ewing sarcoma, and other cancers. The market is also influenced by the increasing number of individuals living with acquired immune deficiency syndrome (AIDS), who are at a higher risk of developing Kaposi's sarcoma[2].

Market Segmentation

The etoposide market is segmented by type and application. Etopophos, a formulation of etoposide phosphate, holds the largest revenue share in the market. The drug is marketed under various names, including Etopophos, Toposar, and Vepesid[2].

Regional Market

The global etoposide market is divided into regions such as North America, Europe, Asia-Pacific, and the rest of the world. Each region's market growth is influenced by local healthcare policies, the incidence of cancer, and the availability of chemotherapy agents[2].

Market Projections

Revenue Growth

The global etoposide market is projected to achieve significant revenue growth, with worldwide sales expected to exceed $1 billion by 2029. This growth is driven by the increasing demand for effective chemotherapy agents and the expanding patient population requiring cancer treatment[5].

Future Developments

Researchers are continually working to improve etoposide's efficacy and mitigate its side effects, such as gastrointestinal toxicity, neurotoxicity, hair loss, and bone marrow suppression. Efforts are also being made to secure sustainable sources of podophyllotoxin, including exploring fungal sources like Fusarium oxysporum and Aspergillus fumigatus[5].

Side Effects and Safety Profile

Common Side Effects

Etoposide phosphate is associated with several side effects, including myelosuppression, which is the dose-limiting toxicity. Other common side effects include gastrointestinal toxicity, neurotoxicity, hair loss, and bone marrow suppression[2][3].

Safety Considerations

Patients with a history of severe allergy to monoclonal antibodies, hypersensitivity to carboplatin or etoposide, or recent myocardial infarction are generally excluded from clinical trials involving etoposide phosphate. Pregnant or breastfeeding women and patients with a history of psychotropic drug abuse are also excluded[1].

Regulatory Approvals and Guidelines

FDA Approvals

Etoposide was first approved by the US FDA in 1983, and since then, it has been included in the World Health Organisation’s Model List of Essential Medicines. Recent approvals, such as the authorization of Imfinzi from AstraZeneca in combination with platinum and etoposide for advanced-stage SCLC, further underscore the drug's importance in cancer treatment[2][5].

Clinical Practice Guidelines

Clinical practice guidelines, such as those from the Hellenic Cooperative Oncology Group, recommend the use of carboplatin and etoposide in the treatment of SCLC. These guidelines are based on randomized Phase III trials that have demonstrated the efficacy of this combination[4].

Conclusion

Etoposide phosphate remains a vital component in the treatment of various cancers, particularly small cell lung cancer. Ongoing clinical trials continue to refine its use and efficacy, while market projections indicate significant growth driven by increasing cancer incidence and the need for effective chemotherapy agents.

Key Takeaways

• Clinical Trials: Ongoing Phase 3 trials compare serplulimab plus chemotherapy with atezolizumab plus chemotherapy in ES-SCLC patients.
• Mechanism of Action: Etoposide phosphate inhibits DNA topoisomerase II, causing DNA strand breaks and apoptotic death in cancer cells.
• Market Growth: The global etoposide market is expected to grow significantly, driven by rising cancer prevalence and demand for chemotherapy.
• Side Effects: Common side effects include myelosuppression, gastrointestinal toxicity, neurotoxicity, hair loss, and bone marrow suppression.
• Regulatory Approvals: Etoposide is included in the WHO’s Model List of Essential Medicines and has recent FDA approvals for combination therapies.

FAQs

What is the primary mechanism of action of etoposide phosphate?

Etoposide phosphate acts by inhibiting DNA topoisomerase II, preventing DNA re-ligation and causing DNA strand breaks, which leads to apoptotic death in cancer cells[2][5].

Which cancers is etoposide phosphate most commonly used to treat?

Etoposide phosphate is most commonly used in the treatment of small cell lung cancer and testicular cancer, among other malignancies[5].

What are the common side effects of etoposide phosphate?

Common side effects include myelosuppression, gastrointestinal toxicity, neurotoxicity, hair loss, and bone marrow suppression[2][3].

What is the current market projection for etoposide phosphate?

The global etoposide market is projected to achieve significant revenue growth, with worldwide sales expected to exceed $1 billion by 2029[5].

Are there ongoing efforts to improve etoposide phosphate?

Yes, researchers are working to improve etoposide's efficacy and mitigate its side effects, as well as exploring sustainable sources of podophyllotoxin[5].

Sources

1. ClinicalTrials.gov: Serplulimab + Chemotherapy (Carboplatin-Etoposide) in US Patients With ES-SCLC.
2. OMR Global: Etoposide Market - Industry reports.
3. PubMed: Clinical studies with etoposide phosphate.
4. EviQ: Small cell lung cancer extensive disease carboplatin and etoposide.
5. LGC Standards: Etoposide: History and mechanism of action.

Last updated: 2025-01-01