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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a combination of chemotherapy drugs—docetaxel, cisplatin, and fluorouracil—in treating nasal cavity and sinus cancer at stages II-IV. These drugs work to stop cancer cells from growing and spreading by either killing them or preventing their division. This trial suits individuals newly diagnosed with locally advanced sinus cancer who have not received prior chemotherapy or radiotherapy in the sinus area. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the combination of docetaxel, cisplatin, and fluorouracil is generally well-tolerated by patients. In past studies, participants experienced manageable side effects. These drugs are already used together for treating other cancers, such as advanced stomach cancer, which supports their safety. Some patients might experience common side effects like nausea or fatigue, but these typically don't last long and can be treated. Overall, evidence suggests that this combination is safe enough for further study in sinus cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of cisplatin, docetaxel, and fluorouracil for sinus cancer because this regimen targets the cancer cells aggressively and comprehensively. Unlike standard treatments that might focus on a single pathway or involve surgery, this combination therapy uses multiple drugs with different mechanisms of action, potentially increasing effectiveness. Moreover, the use of chemoradiotherapy after initial treatment aims to maximize cancer cell destruction while minimizing the chance for disease progression. This approach could offer patients a powerful alternative to existing treatment options.

What evidence suggests that this trial's treatments could be effective for sinus cancer?

Research has shown that a combination of three drugs—docetaxel, cisplatin, and fluorouracil—may help treat cancer in the nasal cavity and nearby sinuses. In this trial, participants will receive this combination as part of the treatment regimen. Studies have found that this drug combo can effectively shrink tumors, which helps protect important areas in the head and neck. Evidence from trials on similar cancers, such as certain types of head and neck cancer, supports its effectiveness. Patients treated with these drugs often saw their tumors stop growing or get smaller. Overall, this treatment has been promising and manageable, offering hope for those dealing with this difficult cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Ehab Y. Hanna

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00707473

Docetaxel, Cisplatin and Fluorouracil in Treating Patients ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39701091/

Phase II Trial of Neoadjuvant Docetaxel/Cisplatin/5 ... Conclusion: TPF NAC showed a promising efficacy and might help preserve critical structures in this population, which needs to be validated in a large ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.6020

A phase II trial of neoadjuvant docetaxel/5-FU/cisplatin in ... Results: Between 2019 and 2023, 28 patients were screened, and 27 received at least one cycle of NAC. The median age was 58 years (range: 41-71) ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419453088

Original articles Head and neck cancer Docetaxel, cisplatin ... The combination of docetaxel, cisplatin and 5-FU associated with prophylactic ciprofloxacin is feasible and active in patients with SCCHN.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa070956

Cisplatin and Fluorouracil Alone or with Docetaxel in Head ... A randomized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck compared induction chemotherapy with docetaxel plus cisplatin ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/201195s019lbl.pdf

docetaxel injection - accessdata.fda.gov Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including ...