Study on Docetaxel, Cisplatin, and Fluorouracil for Treating Stage II-IV Nasal and Sinus Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT00707473

Provider View

This clinical trial is testing a combination of chemotherapy drugs—docetaxel, cisplatin, and fluorouracil—to see how well they work in treating patients with stage II-IV nasal cavity and paranasal sinus cancer who have not received prior treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well a combination of chemotherapy drugs—docetaxel, cisplatin, and fluorouracil—works in treating patients with stage II-IV nasal cavity and paranasal sinus cancer. These drugs aim to stop the growth of cancer cells by killing them, preventing them from dividing, or stopping them from spreading.

Description

The main goals of this study are to determine how many patients have a complete or partial response to the chemotherapy treatment and to improve local tumor control to 80% at 2 years. Secondary goals include evaluating survival rates, organ preservation, patterns of treatment failure, treatment-related side effects, and the impact on quality of life.

Patients will receive chemotherapy with docetaxel, cisplatin, and fluorouracil in cycles every 3 weeks for up to 2 cycles, unless the disease progresses or side effects become unacceptable. If patients respond well, they will receive an additional course of treatment and undergo chemoradiotherapy for 6-7 weeks. If the disease is stable or progresses, or if there is less than a complete response to chemoradiotherapy, patients will undergo surgery and radiation therapy.

After completing the study treatment, patients will have follow-up visits every 3 months for 2 years, every 4 months for 1 year, and every 6 months for 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of locally advanced squamous cell carcinoma, poorly differentiated carcinoma, or sinonasal undifferentiated carcinoma of the nasal cavity and/or paranasal sinuses.
  • Must have stage II-IV disease with measurable tumors.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study.
  • Must be willing to sign an informed consent document and undergo required assessments.

Exclusion Criteria

  • Evidence of cancer spread beyond the collarbone.
  • Pre-existing nerve damage or hearing loss.
  • Prior chemotherapy for cancer within the last 3 years.
  • Prior radiation therapy to the sinus region or upper neck.
  • Previous surgery that removed all visible cancer.
  • Current pregnancy or breastfeeding.
  • History of severe allergic reactions to docetaxel or similar drugs.
  • Known history of HIV infection.

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