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Alkylating agents

Chemotherapy for Sinus Cancer

Phase 2

Waitlist Available

Led By Ehab Y Hanna

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage II-IV disease; tumor (T) 2-4, node (N) any, metastasis (M) 0

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

Must not have

Evidence of distant metastases below the clavicle

Initial surgical resection of the paranasal sinuses or nasal cavity region rendering the patient clinically and radiologically disease free

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

Summary

This trial is testing docetaxel, cisplatin and fluorouracil to see if they can effectively treat patients with previously untreated stage II-IV nasal cavity and/or paranasal sinus cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions to the infusion of drugs like fatigue, nausea, hair loss; damage to organs such as kidneys; nerve damage leading to numbness; increased risk of infection due to low blood cell counts; hearing changes; eye issues related to therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am fully active or can carry out light work.

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I am capable of becoming pregnant and have a negative pregnancy test.

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My cancer diagnosis is one of the specific types affecting my nasal area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to areas below my collarbone.

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I had surgery for sinus or nasal cancer and am now free of signs of the disease.

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I do not have another active cancer or am using experimental drugs.

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I was treated for another cancer less than 3 years ago.

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I am not using or cannot use birth control.

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I have severe nerve pain or damage.

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I have had radiation therapy to my sinus or upper neck area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (docetaxel, cisplatin, and fluorouracil)Experimental Treatment8 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

FDA approved

Quality-of-Life Assessment

2017

Completed Phase 3

~4950

Carboplatin

FDA approved