NCT00707473

Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer

Phase II Trial of Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma and/or Poorly Differentiated Carcinoma of the Nasal Cavity and/or Paranasal Sinuses

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF). II. To improve local tumor control to 80% at 2 years. SECONDARY OBJECTIVES I. Disease specific-survival and overall survival rates. II. Organ preservation (orbital, maxillary, cranial) rate. III. Patterns of treatment failure (local, regional, and distant). IV. Acute and late treatment-related toxicity. V. The effect of treatment on Quality of Life with and without surgery (i.e., M. D. Anderson Symptom Inventory \[MDASI\], M. D. Anderson Dysphagia Inventory \[MDADI\], Xerostomia Questionnaire, Performance Status Scale for Head \& Neck Cancer Patients \[PSS-HN\], etc.). VI. To evaluate the effects of induction chemotherapy on biological markers that could serve as surrogates for response and predictors of long-term outcome. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive docetaxel intravenously (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 complete response (CR) or partial response (PR) receive 1 additional course of treatment and undergo chemoradiotherapy over 6-7 weeks. Patients who have stable disease (SD) or progressive disease (PD) to induction therapy, or less than a complete response to chemoradiotherapy undergo surgery and radiation therapy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 4 months for 1 year and every 6 months for 2 years.

Conditions

• Locally Advanced Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Nasal Cavity and Paranasal Sinus Poorly Differentiated Carcinoma
• Sinonasal Undifferentiated Carcinoma
• Stage II Nasal Cavity and Paranasal Sinus Cancer AJCC v8
• Stage III Nasal Cavity and Paranasal Sinus Cancer AJCC v8
• Stage IVA Nasal Cavity and Paranasal Sinus Cancer AJCC v8
• Stage IVB Nasal Cavity and Paranasal Sinus Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
OTHER	Chemoradiotherapy	Undergo chemoradiotherapy
DRUG	Cisplatin	Given IV
PROCEDURE	Definitive Surgical Resection	Undergo surgery
DRUG	Docetaxel	Given IV
DRUG	Fluorouracil	Given IV
PROCEDURE	Quality-of-Life Assessment	Correlative studies
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

• Start date: 2008-06-16
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2008-06-30
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study