Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Musculoskeletal Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Paranasal Sinus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Nose Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nose Diseases

Respiratory Tract Diseases

Paranasal Sinus Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Sinonasal Undifferentiated Carcinoma

Sinus Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Docetaxel

Fluorouracil

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

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.

Chemoradiotherapy

Definitive Surgical Resection

Quality-of-Life Assessment

Radiation Therapy

Ehab Y Hanna

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.

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.

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

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for nasal cavity and paranasal sinus poorly differentiated carcinoma