Chemotherapy for Sinus Cancer

Overseen By Ehab Hanna

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Metastases, Neuropathy, Hearing loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well docetaxel, cisplatin and fluorouracil work in treating patients with previously untreated stage II-IV nasal cavity and/or paranasal sinus cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer based on your specific situation.

What data supports the effectiveness of this drug for sinus cancer?

Research shows that the combination of docetaxel, cisplatin, and 5-fluorouracil (TPF) is effective in treating advanced head and neck cancers, including sinonasal squamous cell carcinoma, which is similar to sinus cancer. This combination has been shown to be active and feasible in treating these types of cancers. ^{1 2 3 4 5}

Is chemotherapy using Cisplatin, Docetaxel, and Fluorouracil safe for sinus cancer?

The combination of Cisplatin, Docetaxel, and Fluorouracil has been studied for safety in various cancers, including sinus cancer. While it shows promise, it can cause significant side effects like neutropenia (low white blood cell count) and mucositis (painful inflammation of the mouth lining). ^{1 4 6 7 8}

How is the drug combination of Cisplatin, Docetaxel, and Fluorouracil unique for treating sinus cancer?

This drug combination is unique because it combines three powerful cancer-fighting agents, which have shown effectiveness in treating head and neck cancers, including sinus cancer. The combination aims to enhance treatment efficacy by using multiple drugs that work in different ways to attack cancer cells. ^{2 3 4 9 10}

Research Team

Ehab Y. Hanna

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with untreated stage II-IV nasal cavity or paranasal sinus cancer. Participants must have certain blood and organ function levels, be able to perform daily activities (ECOG PS 0-1), not have had prior treatments that would exclude them, and women must test negative for pregnancy. People with severe hearing loss, HIV, other cancers treated within the last 3 years, or those who are pregnant or breastfeeding cannot join.

Inclusion Criteria

My cancer is at stage II-IV, with a tumor size of T2-T4, any node involvement, and no distant metastasis.

Your blood needs to have specific levels of certain components.

You need to have specific signs of the disease that can be measured according to certain criteria.

Exclusion Criteria

Pregnancy or breastfeeding

My cancer has spread to areas below my collarbone.

You have been diagnosed with HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Patients receive docetaxel, cisplatin, and fluorouracil. Cycles repeat every 3 weeks for up to 2 cycles.

6 weeks

Chemoradiotherapy

Patients achieving complete or partial response receive an additional course of treatment and undergo chemoradiotherapy.

6-7 weeks

Surgery and Radiation Therapy

Patients with stable or progressive disease, or less than a complete response to chemoradiotherapy, undergo surgery and radiation therapy.

Follow-up

Participants are monitored for safety and effectiveness after treatment.

5 years

Treatment Details

Interventions

• Cisplatin
• Docetaxel
• Fluorouracil

Trial Overview The study tests how well a combination of chemotherapy drugs—docetaxel, cisplatin and fluorouracil—works against stage II-IV nasal cavity and paranasal sinus cancer when given before any surgery. The effectiveness will be measured by the ability of these drugs to kill tumor cells or stop them from growing and spreading.

Participant Groups

Group I: Treatment (docetaxel, cisplatin, and fluorouracil) Experimental Treatment 8 Interventions

INDUCTION CHEMOTHERAPY: Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 30-180 minutes or carboplatin IV on day 1, and fluorouracil IV continuously on days 1-4. Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve CR or PR receive 1 additional course of treatment and undergo chemoradiotherapy over 6-7 weeks. Patients who have SD or PD to induction therapy, or less than a complete response to chemoradiotherapy undergo surgery and radiation therapy.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 7 patients with advanced sinonasal squamous cell carcinoma, a modified TPF regimen combined with radiotherapy resulted in a complete response in all patients, indicating high efficacy of this treatment approach.

Despite some severe side effects like grade 4 leukopenia and neutropenia in a few patients, the overall safety profile was acceptable, with an impressive 85.7% disease-free survival rate at 60 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Study of Chemoradiotherapy Using Modified Docetaxel, Cis-diaminodichloroplatinum, and 5-Fluorouracil for Sinonasal Squamous Cell Carcinoma. Katagiri, K., Shiga, K., Saito, D., et al.[2022]

The TPF regimen, which includes docetaxel, cisplatin, and 5-fluorouracil, showed a 74% overall response rate and a 24% complete response rate in 46 patients with unresectable stage IV head and neck carcinomas, indicating its efficacy compared to the standard PF regimen.

However, the TPF regimen was associated with significant treatment-related toxicities, including myelosuppression in 78% of patients, suggesting that while it may be more effective, it also carries a higher risk of severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II Study of Docetaxel, Cisplatin and 5- Fluorouracil (TPF) In Patients with Locally Advanced Head and Neck Carcinomas. Ansari, M., Omidvari, S., Mosalaei, A., et al.[2021]

The combination of docetaxel and cisplatin demonstrated a significant overall response rate of 53.7% in patients with locally advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck, indicating its efficacy as a treatment option.

Despite common hematologic and non-hematologic toxicities, the treatment was generally well-tolerated, with serious adverse effects being infrequent due to the use of corticosteroid prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group. Schöffski, P., Catimel, G., Planting, AS., et al.[2020]

In a study involving six patients with maxillary sinus cancer, superselective cisplatin infusion via the ophthalmic artery, combined with radiotherapy, resulted in a complete response and no locoregional recurrences.

However, this treatment approach led to visual acuity loss in four out of six patients, indicating a significant risk that must be considered when using this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ligation of the ethmoid arteries in superselective intra-arterial infusion of cisplatin for advanced maxillary sinus cancer fed by the ophthalmic artery. Tamagawa, K., Shinomiya, H., Okada, T., et al.[2023]

In a retrospective analysis of 371 patients with primary squamous cell carcinomas of the pyriform sinus, those who received multiple-agent chemotherapy had higher survival rates compared to those treated with single-agent chemotherapy.

The study suggests that induction chemotherapy may enhance survival in pyriform sinus cancers, but further prospective studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of survival after induction chemotherapy in pyriform sinus carcinoma. Brasnu, D., Fabre, A., Menard, M., et al.[2019]

The TP regimen (docetaxel combined with cisplatin) showed similar efficacy to the PF regimen (cisplatin combined with 5-fluorouracil) in treating nasopharyngeal carcinoma, with both regimens achieving high rates of complete remission after concurrent chemoradiotherapy.

However, the TP regimen was associated with significantly higher rates of severe neutropenia compared to the PF regimen, indicating a need for careful monitoring of blood cell counts during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of efficacy of docetaxel combined cisplatin (TP regimen) and cisplatin combined 5-fluorouracil (PF regimen) on locally advanced nasopharyngeal carcinoma]. Xie, FY., Qi, SN., Hu, WH., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preliminary Study of Chemoradiotherapy Using Modified Docetaxel, Cis-diaminodichloroplatinum, and 5-Fluorouracil for Sinonasal Squamous Cell Carcinoma. [2022]

2. Estonia pubmed.ncbi.nlm.nih.gov

A Phase II Study of Docetaxel, Cisplatin and 5- Fluorouracil (TPF) In Patients with Locally Advanced Head and Neck Carcinomas. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Ligation of the ethmoid arteries in superselective intra-arterial infusion of cisplatin for advanced maxillary sinus cancer fed by the ophthalmic artery. [2023]

5. Greece pubmed.ncbi.nlm.nih.gov

Adjuvant docetaxel, cisplatin and 5-fluorouracil (TPF) in locally advanced squamous cell carcinoma of the head and neck. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Docetaxel in combination with fluorouracil for advanced solid tumors. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Sequential chemoradiation in locally advanced head and neck cancer after induction chemotherapy: an induction chemotherapy schedule more suited to a limited resource setting. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Docetaxel in squamous cell cancer of the head and neck. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Analysis of survival after induction chemotherapy in pyriform sinus carcinoma. [2019]

10. China pubmed.ncbi.nlm.nih.gov

[Comparison of efficacy of docetaxel combined cisplatin (TP regimen) and cisplatin combined 5-fluorouracil (PF regimen) on locally advanced nasopharyngeal carcinoma]. [2022]