Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: The goal of this clinical research study is to learn if docetaxel, 5-fluorouracil, and either cisplatin or carboplatin in combination, then followed by chemoradiotherapy is effective in controlling cancers of the paranasal sinuses.

Detailed Summary:

The Study Drugs:

Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in cancer cells as well.

Cisplatin has an atom at its center that contains platinum. The platinum is supposed to poison the cancer cells, which may cause them to die.

Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.

5-Fluorouracil is designed to destroy cancer cells by preventing them from dividing and multiplying .

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive 5-fluorouracil through a needle in your vein, non-stop, on Days 1-4 of each 21-day study "cycle". On Day 1 only, you will receive docetaxel over 1 hour and cisplatin over 30-180 minutes. You will receive 2-3 cycles of therapy.

If the study doctor thinks that it is in your best interest, you may receive carboplatin in place of cisplatin.

If you are having side effects, the study doctor may schedule you to receive the study drugs on a longer cycle.

Study Visits:

During Weeks 1-3 of Cycles 1 and 2, you will have study visits during the week that you receive chemotherapy treatment. At these visits, the following tests and procedures will be performed:

• Blood (about 2 teaspoons) will
  Sponsor: M.D. Anderson Cancer Center
  

  Current Primary Outcome: Number of Patients with Complete + Partial Response [ Time Frame: Response assessment after two 3 week cycles, then every 6 months for minimally 2 years ]

  Clinical/radiographic complete and partial responses after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF) where Complete Response (CR): Disappearance of clinical and radiological evidence of tumor; Partial Response (PR): 50% or > decrease in overall sum of products of diameters of all target lesions in reference to baseline sum. PR defined as a 30% or > reduction in dimension target lesions; Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR; Progressive Disease (PD): 25% or > increase in overall sum products of diameters of all target lesions reference smallest sum recorded at or following baseline. PD is defined as a 20% or > increase in dimension of target lesions. Tumors measurable by only one dimension assessed by Response Evaluation Criteria In Solid Tumors (RECIST).
  
  
  

  Original Primary Outcome: The goal of this clinical research study is to learn if docetaxel, cisplatin, and 5-fluorouracil in combination can help to control the disease in patients with cancer of the paranasal sinuses. [ Time Frame: 3 Years ]
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: M.D. Anderson Cancer Center
  

  Dates:
  Date Received: June 26, 2008
  Date Started: June 2008
  Date Completion:
  Last Updated: August 22, 2016
  Last Verified: August 2016