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

Who is this study for? Adult patients with advanced squamous cell cardinoma of the nasal cavity and/or paranasal sinuses
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug, Procedure, Radiation, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 17
Healthy Volunteers: f
View:

• Patients must have a confirmed (by a MD Anderson Cancer Center \[MDACC\] pathologist) cytologic or histological diagnosis of locally advanced squamous cell carcinoma, poorly differentiated carcinoma, or sinonasal undifferentiated carcinoma of the nasal cavity and/or paranasal sinuses.

• Stage II-IV disease; tumor (T) 2-4, node (N) any, metastasis (M) 0. Measurable disease is required with the following criteria: Measurable lesions can be accurately measured, with at least one diameter \>= 1.0 cm by spiral computed tomography (CT) scan or magnetic resonance imaging (MRI). Lesions can be bidimensionally measurable or unidimensionally measurable. Every effort should be made to measure lesions in two dimensions. Measurable disease is present if the patient has one or more measurable lesions. Non-measurable lesions/disease are all other lesions, including small lesions (those with measurements \< 2.0 cm; or \< 1.0 cm with spiral CT).

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

• Absolute peripheral granulocyte count (AGC) of \>= 1500 cells/mm\^3.

• Platelet count of \>= 100,000 cells/mm\^3.

• Total bilirubin =\< upper limit of normal (ULN). If the patient has a history of Gilbert's Syndrome, check direct and indirect bilirubin. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria.

• Alkaline phosphatase =\< 2 x ULN. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria.

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2 x ULN. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria.

• Hemoglobin \>= 10.0g/dL.

• Per MDACC creatinine clearance (CrCl) guidelines, patients must have a creatinine clearance \> 50 ml/min determined by 24 hour collection or nomogram

• Patients should have uncontrolled intercurrent illness, which in the opinion of the attending medical oncologist, would render the patient unsuitable for the study (i.e., preclude safe administration of the prescribed chemotherapy treatment).

• Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (i.e., minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]), within 72 hours prior to the start of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician(s) immediately.

• Ability to understand and the willingness to sign a written Informed Consent Document (ICD). In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC Policy For Consenting Non-English Speaking Participants.

• Willingness to undergo MDACC Audiology and Ophthalmology Assessment.

Locations
United States
Texas
M D Anderson Cancer Center
Houston
Time Frame
Start Date: 2008-06-16
Completion Date: 2025-09-30
Participants
Target number of participants: 31
Treatments
Experimental: Treatment (docetaxel, cisplatin, and fluorouracil)
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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